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KAMALA D HARRIS Attorney General of California DIANN SOKOLOFF Supervising Deputy AttofneyUeneral SHEILA J VASANTHARAM Deputy Attorney General State Bar No 289217

1515 Clay Street 20th Floor PO Box 70550 Oakland CA 94612-0550 Telephone (51 0) 622-2141 Facsimile (51 0) 622-2270 E-mail SheilaVasantharamdojcagov

Attorneys for Complainant

BEFORE THE BOARD OF PHARMACY

DEPARTMENT OF CONSUMER AFFAIRS STATE OF CALIFORNIA

In the Matter of the Accusation Against SAN DIMAS PHARMACY amp COMPOUNDING CENTER KALPANA PATEL AKA KALPANA KALPESHKUMAR PATEL President 3805 San Dimas Street Suite A Bakersfield CA 93301

Pharmacy Permit No PHY 48922

and

KALIgtANA PATEL AKA KALPANA KALPESHKUMAR PATEL 5111 Vista Rica Court Bakersfield CA 93311

Pharmacist License No RPH 49676

Respondents

Case No 5192

ACCUSATION

Complainant alleges

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PARTIES

I Virginia Herold (Complainant) brings this Accusation solely in her official capacity

as the Executive Officer of the Board of Pharmacy Department of Consumer Affairs

32 On or about January 7 2008 the Board of Pharmacy issued Pharmacy Permit

Number PHY 48922 to San Dimas Pharmacy amp Compounding Center (Respondent San Dimas)

The Pharmacy Permit was in full force and effect at all times relevant to the charges brought in

this Accusation and will expire on January I 2016 unless renewed

3 On or about August 22 1997 the Board of Pharmacy issued Pharmacist License

Number RPH 49676 to Kalpana Patel also known as Kalpana Kalpeshkumar Patel (Respondent

Patel) The Pharmacist License was in full force and effect at all times relevant to the charges

brought in this Accusation and will expire on November 302016 unless renewed

JURISDICTION

4 This Accusation is brought before the Board of Pharmacy (Board) Department of

Consumer Affairs under the authority of the following laws All section references are to the

Business and Professions Code unless otherwise indicated

5 Section 4011 of the Code provides that the Board shall administer and enforce both

the Pharmacy Law [Bus amp Prof Code sect 4000 et seq] and the Uniform Controlled Substances

Act [Health amp Safety Code sect 11000 et seq]

6 Section 4300 of the Code states in pertinent part

(a) Every license issued may be suspended or revoked

(b) The board shall discipline the holder of any license issued by the board whose default

has been entered or whose case has been heard by the board and found guilty by any of the

following methods

(1) Suspending judgment

(2) Placing him or her upon probation

(3) Suspending his or her right to practice for a period not exceeding one year

(4) Revoking his or her license

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(5) Taking any other action in relation to disciplining him or her as the board in its

discretion may deem proper

(e) The proceedings under this article shall be conducted in accordance with Chapter 5

(commencing with Section 11500) of Part I of Division 3 of the Government Code and the board

shall have all the powers granted therein The action shall be final except that the propriety of

the action is subject to review by the superior court pursuant to Section I 0945 of the Code of

Civil Procedure

7 Section 43001 of the Code states

The expiration cancellation forfeiture or suspension of a board-issued license by

operation of law or by order or decision ofthe board or a court of law the placement of a license

on a retired status or the voluntary surrender of a license by a licensee shall not deprive the board

ofjurisdiction to commence or proceed with any investigation of or action or disciplinary

proceeding against the licensee or to render a decision suspending or revoking the license

STATUTORYREGULATORY PROVISIONS

8 Section 4040 of the Code states in pertinent part

(a) Prescription means an oral written or electronic transmission order that is both of

the following

(I) diven individually for the person or persons for whom ordered that includes all of the

following

(A) The name or names and address of the patient or patients

(B) The name and quantity of the drug or device prescribed and the directions for use

(C) The date of issue

(D) Either rubber stamped typed or printed by hand or typeset the name address and

telephone number of the prescriber his or her license classification and his or her federal registry

number if a controlled substance is prescribed

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(E) A legible clear notice ofthe condition or purpose for which the drug is being

prescribed if requested by the patient or patients

(F) If in writing signed by the prescriber issuing the order or the certified nurse-midwife

nurse practitioner physician assistant or naturopathic doctor who issues a drug order pursuant to

Section 274651 28361 35021 or 36405 respectively or the pharmacist who issues a drug

order pursuant to Section 40521 40522 or 40526

9 S~ction 4051 of the Code states in pertinent part

(a) Except as otherwise provided in this chapter it is unlawful for any person to

manufacture compound furnish sell or dispense a dangerous drug or dangerous device or to

dispense or compound a prescription pursuant to Section 4040 of a prescriber unless he or she is a

pharmacist under this chapter

10 Section 4301 ofthe Code states in pertinent part

The board shall take action against any holder of a license who is guilty of unprofessional

conduct or whose license has been procured by fraud or misrepresentation or issued by mistake

Unprofessional conduct shall include but is not limited to any of the following

(f) The commission of any act involving moral turpitude dishonesty fraud deceit or

corruption whether the act is committed in the course of relations as a licensee or otherwise and

whether the act is a felony or misdemeanor or not

(g) Knowingly making or signing any certificate or other document that falsely represents

the existence or nonexistence of a state of facts

II Section 4307 of the Code states

(a) Any person who has been denied a license or whose license has been revoked or is

under suspension or who has failed to renew his or her license while it was under suspension or

who has been a manager administrator owner member officer director associate or partner of

any partnership corporation firm or association whose application for a license has been denied

or revoked is under suspension or has been placed on probation and while acting as the manager

administrator owner member officer director associate or partner had knowledge of or

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knowingly participated in any conduct for which the license was denied revoked suspended or

placed on probation shall be prohibited from serving as a manager administrator owner

member officer director associate or partner of a licensee as follows

()Where a probationary license is issued or where an existing license is placed on

probation this prohibition shall remain in effect for a period not to exceed five years

(2) Where the license is denied or revoked the prohibition shall continue until the license

is issued or reinstated

(b) Manager administrator owner member officer director associate or partner as

used in this section and Section 4308 may refer to a pharmacist or to any other person who

serves in that capacity in or for a licensee

(c) The provisions of subdivision (a) may be alleged in any pleading filed pursuant to

Chapter 5 (commencing with Section 11500) of Part I of Division 3 of the Government Code

However no order may be issued in that case except as to a person who is named in the caption

as to whom the pleading alleges the applicability of this section and where the person has been

given notice of the proceeding as required by Chapter 5 (commencing with Section 11500) of

Part I of Division 3 of the Government Code The authority to proceed as provided by this

subdivision shall be in addition to the boards authority to proceed under Section 4339 or any

other provision of law

12 Section 11164 of the Health and Safety Code states in pertinent part

Except as provided in Section 11167 no person shall prescribe a controlled substance nor

shall any person fill compound or dispense a prescription for a controlled substance unless it

complies with the requirements of this section

(a) Each prescription for a controlled substance classified in Schedule II Ill IV or V

except as authorized by subdivision (b) shall be made on a controlled substance prescription

form as specified in Section 111621 and shall meet the following requirements

(1) The prescription shall be signed and dated by the prescriber in ink and shall contain the

prescribers address and telephone number the name of the ultimate user or research subject or

contact information as determined by the Secretary of the United States Department of Health and

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Human Services refill information such as the number of refills ordered and whether the

prescription is a first-time request or a refill and the name quantity strength and directions for

use of the controlled substance prescribed

13 Section 11167 of the Health and Safety Code states

Notwithstanding subdivision (a) of Section 11164 in an emergency where failure to issue

a prescription may result in loss oflife or intense suffering an order for a controlled substance

may be dispensed on an oral order an electronic data transmission order or a written order not

made on a controlled substance form as specified in Section 111621 subject to all of the

following requirements

(a) The order contains all information required by subdivision (a) of Section 11164

(b) Any written order is signed and dated by the prescriber in ink and the pharmacy

reduces any oral or electronic data transmission order to hard copy form prior to dispensing the

controlled substance

(c) The prescriber provides a written prescription on a controlled substance prescription

form that meets the requirements of Section 111621 by the seventh day following the

transmission of the initial order a postmark by the seventh day following transmission of the

initial order shall constitute compliance

(d) If the prescriber fails to comply with subdivision (c) the pharmacy shall so notifY the

Department of Justice in writing within 144 hours of the prescribers failure to do so and shall

make and retain a hard copy readily retrievable record of the prescription including the date and

method of notification of the Department of Justice

(e) This section shall become operative on January I 2005

14 Section 11200 of the Health and Safety Code states in pertinent part

(b) No prescription for a Schedule lii or IV substance may be refilled more than five times

and in an amount for all refills of that prescription taken together exceeding a 120-day supply

15 California Code of Regulations title 16 section 1717 states in pertinent part

Promptly upon receipt of an orally transmitted prescription the pharmacist shall reduce it

to writing and initial it and identity it as an orally transmitted prescription If the prescription is

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then dispensed by another pharmacist the dispensing pharmacist shall also initial the prescription

to identify him or herself All orally transmitted prescriptions shall be received and transcribed by

a pharmacist prior to compounding filling dispensing or furnishing Chart orders as defined in

section 4019 of the Business and Professions Code are not subject to the provisions of this

subsection

16 California Code of Regulations title 16 section 17352 states in pertinent part

(f) The pharmacist performing or supervising compounding is responsible for the integrity

potency quality and labeled strength of a compounded drug product until it is dispensed

(h) Every compounded drug product shall be given an expiration date representing the date

beyond which in the professional judgment of the pharmacist performing or supervising the

compounding it should not be used This beyond use date of the compounded drug product

shall not exceed 180 days from preparation or the shortest expiration date of any component in

the compounded drug product unless a longer date is supported by stability studies of finished

drugs or compounded drug products using the same components and packaging Shorter dating

than set forth in this subsection may be used if it is deemed appropriate in the professional

judgment of the responsible pharmacist

17 California Code of Regulations title 16 section 17353 states in pertinent part

(a) For each compounded drug product the pharmacy records shall include

(I) The master formula record

(2) The date the drug product was compounded

(3) The identity of the pharmacy personnel who compounded the drug product

(4) The identity of the pharmacist reviewing the final drug product

(5) The quantity of each component used in compounding the drug product

~(6) The manufacturer expiration date and lot number of each component lfthe

manufacturer name is demonstrably unavailable the name of the supplier may be substituted

Exempt from the requirements in this paragraph are sterile products compounded on a one-time

basis for administration within seventy-two (72) hours and stored in accordance with standards

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for Redispensed CSPS found in Chapter 797 of the United States Pharmacopeia- National

Formulary (USP-NF) (35th Revision Effective May I 2012) hereby incorporated by reference

to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code

(7) A pharmacy assigned reference or lot number for the compounded drug product

(8) The expiration date of the final compounded drug product

(9) The quantity or amount of drug product compounded

18 Code of Federal Regulations title 21 section 130404 states in pertinent part

(f) Each registered manufacturer distributor importer exporter narcotic treatment

program and compounder for narcotic treatment program shall maintain inventories and records

of controlled substances as follows

(2) Inventories and records of controlled substances listed in Schedules III IV and V shall

be maintained either separately from all other records of the registrant or in such form that the

information required is readily retrievable from the ordinary business records of the registrant

CONTROLLED SUBSTANCES

19 Section 4021 of the Code states

Controlled substance means any substance listed in Chapter 2 (commencing with Section

11 053) of Division 10 of the Health and Safety Code

20 Oxycodone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(M)

21 Morphine is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(L)

22 Vyvanase is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (d)2)

23 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)(14)

24 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)14)

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25 Ketamine is a Schedule III controlled substance as designated by Health and Safety

Code section II 056 subdivision (g)

COST RECOVERY

26 Code section 1253 states in part that the Board may request the administrative law

judge to direct a licentiate found to have committed a violation or violations of the licensing act

to pay a sum not to exceed the reasonable costs of the investigation and enforcement of the case

FACTUALSTATEMENT

27 From about January 1 2008 to the present Respondent San Dimas Pharmacy amp

Compounding Center (Respondent San Dimas) has been operating as a pharmacy in Bakersfield

California From about January 7 2008 to the present Kalpana Patel (Respondent Patel) has

been the pharmacist-in-charge (PIC) at Respondent San Dimas

2012 Complaint and Investigation

28 On or about May 9 2012 a private individual submitted an online complaint to the

Board alleging that Respondent San Dimas was committing various license violations including

filling faxed copies of prescriptions in non-emergency situations and failing to obtain the original

hard copies of the prescriptions until much later and sometimes submitting invoices to insurance

companies for larger quantities of medication than the pharmacy actually dispensed to the

insurance companies customers and never giving the customers their remaining balance of

medication

29 On or about August 292012 in response to the complaint a Board inspector

(inspector) conducted an inspection at Respondent San Dimas

30 While at the pharmacy the inspector found five prescriptions for Schedule II

controlled substances that the pharmacy had filled even though the prescriptions were not signed

and dated in ink by the original prescriber The specifics ofthe five prescriptions are as follows

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a A prescription dated August 24 2012 for oxycodone The prescription was a

photocopy of the original prescription The prescription was not signed and dated in ink by the

prescriber

b A prescription dated March 15 2012 for methadone The prescription was on a

faxed refill authorization request form The prescription was not signed and dated in ink by the

prescriber

c A prescription dated March 172012 for morphine The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

d A prescription dated April 6 2012 for oxycodone The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

e A prescription dated May 162012 for Vyvanse The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

31 Respondent Patel told the inspector that she filled these five prescriptions for

Schedule II controlled substances without the required signatures because there was a possibility

the patients would run out of their medications while their doctors offices were closed The

inspector informed Respondent Patel that she could not provide Schedule II controlled substances

without a properly signed prescription unless there was a true emergency situation meaning that

not providing the medication would result in harm to the patient The inspector did not believe

that the patients with the five prescriptions in question had been in true emergency situations

32 Respondents San Dimas and Patel did not obtain the original prescriptions signed

and dated in ink by the prescriber within seven days of filling the prescriptions The investigator

asked Respondents San Dimas and Patel to show her the original prescriptions but they could not

produce these documents

33 The inspector found a folder in the pharmacy containing many labels bearing the

words balance owed The inspector determined that these labels showed the quantity of

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medications still owed to patients on prescriptions that they had purchased from Respondent San

Dimas

34 Respondent Patel did not reverse the insurance claims she submitted for the

prescriptions where there was a balanced owed She also did not resubmit the claims for the

actual quantity of medication the pharmacy had provided to the patient Respondent Patel instead

waited for the patients who were owed additional medication to return to the pharmacy to request

the balance owed

35 From approximately September 24 2010 to August 152012 Respondents San

Dimas and Patel failed to completely fill 178 prescriptions and submit invoices to the insurance

companies for the amount of medication the pharmacy actually dispensed None of the patients

for these 178 prescriptions returned to the pharmacy and claimed their owed balances of

medication

2013 Investigation

36 On or about August 282013 Board inspectors (inspectors) conducted another

inspection at Respondent San Dimas

37 One of the inspectors found that Respondents had expired and non-expired bulk stock

medications intermixed on their active use medication shelving The inspector reviewed

Respondents completed compounding log sheets and found that several of the expired products

had been used to prepare compounded products with an assigned beyond use date greater than the

expiration date of at least one of the ingredients

38 The inspectors notiCed that a number of entries on Respondents compounding log

sheets were incomplete because Respondents failed to include necessary documentation

including the ingredient lot numbers manufacturers name andor ingredient expiration dates

Respondents failed to include the generic active ingredients on many of the labels on the

compounded drugs

39 The inspectors noticed that Respondents had a number of containers labeled sample I cream on the premises Respondents said that occasionally when their customers had to wait

for approval from their insurance companies for payment for a compound drug Respondents

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staff members would ask the patients physicians for permission to provide sample creams

during the interim period

40 One of Respondents pharmacy technicians would speak with patients physicians

offices to ask for approval to give patients sample cream The technicians would write down

the order for the sample cream on the original prescription copy The sample creams contained

dangerous drugs The orders were not valid prescriptions because a pharmacist did not orally

receive them and a physician did not handwrite or transmit them The approved prescriptions

were incomplete because they did not include the name of the physicians offices staff member

who authorized the prescription the list of ingredients the quantity or length of time directions

or the initials of Respondents staff member who received the oral prescription

41 Many of the compound prescriptions were on pre-printed prescription forms provided

by Respondents to the patients physicians offices Respondents preprinted prescription forms

which included controlled substance prescriptions were multiple check-off prescription blank

forms Three ofthe prescription formulas on the preprinted prescription forms contained

ketamine a controlled substance Prescriptions for controlled substance are required to be

written on a secure blank prescription form faxed with a physicians signature and date or orally

prescribed by the patients physician to the pharmacist Respondents controlled substance preshy

printed prescriptions were not on secure blank prescription forms or orally received by

Respondents pharmacists

42 On one of the physician-approved prescriptions for the Schedule lii controlled

substance ketamine the physician authorized 11 refills and did not record the date on which she

approved the prescription

43 Respondents failed to identify ketamine as a Schedule lii controlled substance in their

compounding software program Due to this oversight Respondents did not record prescriptions

using or incorporating ketamine as controlled substance prescriptions Respondents did not

ensure that prescriptions using or incorporating ketamine were written on secure blank

prescription forms or that oral prescriptions using or incorporating ketamine were only received

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by the pharmacist Respondents did not report prescriptions using or incorporating ketamine to

the Controlled Substance Utilization Review and Evaluation System (CURES)

44 On or about December 17 2013 Respondents dispensed a prescription for T3fT4

Mixture C 2080 mg capsules A qualitative analysis report taken on or about February 21 2014

revealed that the T4 (Levothyroxine Sodium) component of the compounded drug was sub-potent

because the T 4 was 735 of the expected potency

FIRST CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(l))

45 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in ink by

the prescribers (Health amp Saf Codesect 11164 subd (a)(1)) The circumstances are further

explained in paragraphs 30 to 32 above

SECOND CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

46 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action

because it filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Code sect 11167) Respondent San Dimas also failed to obtain the

original prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

THIRD CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Prof Codesect 4301 subd (f))

47 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging in unprofessional conduct because it committed acts involving fraud (Bus amp Prof

Codesect 4301 subd (f)) Respondent San Dimas left a balance of medications owing on 178 of

the prescriptions it sold The circumstances are further explained in paragraphs 34 to 35 above

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Ill

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FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

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- - - - - -- - -- - ---2

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SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

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and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

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THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

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SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

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(5) Taking any other action in relation to disciplining him or her as the board in its

discretion may deem proper

(e) The proceedings under this article shall be conducted in accordance with Chapter 5

(commencing with Section 11500) of Part I of Division 3 of the Government Code and the board

shall have all the powers granted therein The action shall be final except that the propriety of

the action is subject to review by the superior court pursuant to Section I 0945 of the Code of

Civil Procedure

7 Section 43001 of the Code states

The expiration cancellation forfeiture or suspension of a board-issued license by

operation of law or by order or decision ofthe board or a court of law the placement of a license

on a retired status or the voluntary surrender of a license by a licensee shall not deprive the board

ofjurisdiction to commence or proceed with any investigation of or action or disciplinary

proceeding against the licensee or to render a decision suspending or revoking the license

STATUTORYREGULATORY PROVISIONS

8 Section 4040 of the Code states in pertinent part

(a) Prescription means an oral written or electronic transmission order that is both of

the following

(I) diven individually for the person or persons for whom ordered that includes all of the

following

(A) The name or names and address of the patient or patients

(B) The name and quantity of the drug or device prescribed and the directions for use

(C) The date of issue

(D) Either rubber stamped typed or printed by hand or typeset the name address and

telephone number of the prescriber his or her license classification and his or her federal registry

number if a controlled substance is prescribed

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(E) A legible clear notice ofthe condition or purpose for which the drug is being

prescribed if requested by the patient or patients

(F) If in writing signed by the prescriber issuing the order or the certified nurse-midwife

nurse practitioner physician assistant or naturopathic doctor who issues a drug order pursuant to

Section 274651 28361 35021 or 36405 respectively or the pharmacist who issues a drug

order pursuant to Section 40521 40522 or 40526

9 S~ction 4051 of the Code states in pertinent part

(a) Except as otherwise provided in this chapter it is unlawful for any person to

manufacture compound furnish sell or dispense a dangerous drug or dangerous device or to

dispense or compound a prescription pursuant to Section 4040 of a prescriber unless he or she is a

pharmacist under this chapter

10 Section 4301 ofthe Code states in pertinent part

The board shall take action against any holder of a license who is guilty of unprofessional

conduct or whose license has been procured by fraud or misrepresentation or issued by mistake

Unprofessional conduct shall include but is not limited to any of the following

(f) The commission of any act involving moral turpitude dishonesty fraud deceit or

corruption whether the act is committed in the course of relations as a licensee or otherwise and

whether the act is a felony or misdemeanor or not

(g) Knowingly making or signing any certificate or other document that falsely represents

the existence or nonexistence of a state of facts

II Section 4307 of the Code states

(a) Any person who has been denied a license or whose license has been revoked or is

under suspension or who has failed to renew his or her license while it was under suspension or

who has been a manager administrator owner member officer director associate or partner of

any partnership corporation firm or association whose application for a license has been denied

or revoked is under suspension or has been placed on probation and while acting as the manager

administrator owner member officer director associate or partner had knowledge of or

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knowingly participated in any conduct for which the license was denied revoked suspended or

placed on probation shall be prohibited from serving as a manager administrator owner

member officer director associate or partner of a licensee as follows

()Where a probationary license is issued or where an existing license is placed on

probation this prohibition shall remain in effect for a period not to exceed five years

(2) Where the license is denied or revoked the prohibition shall continue until the license

is issued or reinstated

(b) Manager administrator owner member officer director associate or partner as

used in this section and Section 4308 may refer to a pharmacist or to any other person who

serves in that capacity in or for a licensee

(c) The provisions of subdivision (a) may be alleged in any pleading filed pursuant to

Chapter 5 (commencing with Section 11500) of Part I of Division 3 of the Government Code

However no order may be issued in that case except as to a person who is named in the caption

as to whom the pleading alleges the applicability of this section and where the person has been

given notice of the proceeding as required by Chapter 5 (commencing with Section 11500) of

Part I of Division 3 of the Government Code The authority to proceed as provided by this

subdivision shall be in addition to the boards authority to proceed under Section 4339 or any

other provision of law

12 Section 11164 of the Health and Safety Code states in pertinent part

Except as provided in Section 11167 no person shall prescribe a controlled substance nor

shall any person fill compound or dispense a prescription for a controlled substance unless it

complies with the requirements of this section

(a) Each prescription for a controlled substance classified in Schedule II Ill IV or V

except as authorized by subdivision (b) shall be made on a controlled substance prescription

form as specified in Section 111621 and shall meet the following requirements

(1) The prescription shall be signed and dated by the prescriber in ink and shall contain the

prescribers address and telephone number the name of the ultimate user or research subject or

contact information as determined by the Secretary of the United States Department of Health and

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Human Services refill information such as the number of refills ordered and whether the

prescription is a first-time request or a refill and the name quantity strength and directions for

use of the controlled substance prescribed

13 Section 11167 of the Health and Safety Code states

Notwithstanding subdivision (a) of Section 11164 in an emergency where failure to issue

a prescription may result in loss oflife or intense suffering an order for a controlled substance

may be dispensed on an oral order an electronic data transmission order or a written order not

made on a controlled substance form as specified in Section 111621 subject to all of the

following requirements

(a) The order contains all information required by subdivision (a) of Section 11164

(b) Any written order is signed and dated by the prescriber in ink and the pharmacy

reduces any oral or electronic data transmission order to hard copy form prior to dispensing the

controlled substance

(c) The prescriber provides a written prescription on a controlled substance prescription

form that meets the requirements of Section 111621 by the seventh day following the

transmission of the initial order a postmark by the seventh day following transmission of the

initial order shall constitute compliance

(d) If the prescriber fails to comply with subdivision (c) the pharmacy shall so notifY the

Department of Justice in writing within 144 hours of the prescribers failure to do so and shall

make and retain a hard copy readily retrievable record of the prescription including the date and

method of notification of the Department of Justice

(e) This section shall become operative on January I 2005

14 Section 11200 of the Health and Safety Code states in pertinent part

(b) No prescription for a Schedule lii or IV substance may be refilled more than five times

and in an amount for all refills of that prescription taken together exceeding a 120-day supply

15 California Code of Regulations title 16 section 1717 states in pertinent part

Promptly upon receipt of an orally transmitted prescription the pharmacist shall reduce it

to writing and initial it and identity it as an orally transmitted prescription If the prescription is

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then dispensed by another pharmacist the dispensing pharmacist shall also initial the prescription

to identify him or herself All orally transmitted prescriptions shall be received and transcribed by

a pharmacist prior to compounding filling dispensing or furnishing Chart orders as defined in

section 4019 of the Business and Professions Code are not subject to the provisions of this

subsection

16 California Code of Regulations title 16 section 17352 states in pertinent part

(f) The pharmacist performing or supervising compounding is responsible for the integrity

potency quality and labeled strength of a compounded drug product until it is dispensed

(h) Every compounded drug product shall be given an expiration date representing the date

beyond which in the professional judgment of the pharmacist performing or supervising the

compounding it should not be used This beyond use date of the compounded drug product

shall not exceed 180 days from preparation or the shortest expiration date of any component in

the compounded drug product unless a longer date is supported by stability studies of finished

drugs or compounded drug products using the same components and packaging Shorter dating

than set forth in this subsection may be used if it is deemed appropriate in the professional

judgment of the responsible pharmacist

17 California Code of Regulations title 16 section 17353 states in pertinent part

(a) For each compounded drug product the pharmacy records shall include

(I) The master formula record

(2) The date the drug product was compounded

(3) The identity of the pharmacy personnel who compounded the drug product

(4) The identity of the pharmacist reviewing the final drug product

(5) The quantity of each component used in compounding the drug product

~(6) The manufacturer expiration date and lot number of each component lfthe

manufacturer name is demonstrably unavailable the name of the supplier may be substituted

Exempt from the requirements in this paragraph are sterile products compounded on a one-time

basis for administration within seventy-two (72) hours and stored in accordance with standards

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for Redispensed CSPS found in Chapter 797 of the United States Pharmacopeia- National

Formulary (USP-NF) (35th Revision Effective May I 2012) hereby incorporated by reference

to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code

(7) A pharmacy assigned reference or lot number for the compounded drug product

(8) The expiration date of the final compounded drug product

(9) The quantity or amount of drug product compounded

18 Code of Federal Regulations title 21 section 130404 states in pertinent part

(f) Each registered manufacturer distributor importer exporter narcotic treatment

program and compounder for narcotic treatment program shall maintain inventories and records

of controlled substances as follows

(2) Inventories and records of controlled substances listed in Schedules III IV and V shall

be maintained either separately from all other records of the registrant or in such form that the

information required is readily retrievable from the ordinary business records of the registrant

CONTROLLED SUBSTANCES

19 Section 4021 of the Code states

Controlled substance means any substance listed in Chapter 2 (commencing with Section

11 053) of Division 10 of the Health and Safety Code

20 Oxycodone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(M)

21 Morphine is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(L)

22 Vyvanase is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (d)2)

23 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)(14)

24 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)14)

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25 Ketamine is a Schedule III controlled substance as designated by Health and Safety

Code section II 056 subdivision (g)

COST RECOVERY

26 Code section 1253 states in part that the Board may request the administrative law

judge to direct a licentiate found to have committed a violation or violations of the licensing act

to pay a sum not to exceed the reasonable costs of the investigation and enforcement of the case

FACTUALSTATEMENT

27 From about January 1 2008 to the present Respondent San Dimas Pharmacy amp

Compounding Center (Respondent San Dimas) has been operating as a pharmacy in Bakersfield

California From about January 7 2008 to the present Kalpana Patel (Respondent Patel) has

been the pharmacist-in-charge (PIC) at Respondent San Dimas

2012 Complaint and Investigation

28 On or about May 9 2012 a private individual submitted an online complaint to the

Board alleging that Respondent San Dimas was committing various license violations including

filling faxed copies of prescriptions in non-emergency situations and failing to obtain the original

hard copies of the prescriptions until much later and sometimes submitting invoices to insurance

companies for larger quantities of medication than the pharmacy actually dispensed to the

insurance companies customers and never giving the customers their remaining balance of

medication

29 On or about August 292012 in response to the complaint a Board inspector

(inspector) conducted an inspection at Respondent San Dimas

30 While at the pharmacy the inspector found five prescriptions for Schedule II

controlled substances that the pharmacy had filled even though the prescriptions were not signed

and dated in ink by the original prescriber The specifics ofthe five prescriptions are as follows

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a A prescription dated August 24 2012 for oxycodone The prescription was a

photocopy of the original prescription The prescription was not signed and dated in ink by the

prescriber

b A prescription dated March 15 2012 for methadone The prescription was on a

faxed refill authorization request form The prescription was not signed and dated in ink by the

prescriber

c A prescription dated March 172012 for morphine The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

d A prescription dated April 6 2012 for oxycodone The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

e A prescription dated May 162012 for Vyvanse The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

31 Respondent Patel told the inspector that she filled these five prescriptions for

Schedule II controlled substances without the required signatures because there was a possibility

the patients would run out of their medications while their doctors offices were closed The

inspector informed Respondent Patel that she could not provide Schedule II controlled substances

without a properly signed prescription unless there was a true emergency situation meaning that

not providing the medication would result in harm to the patient The inspector did not believe

that the patients with the five prescriptions in question had been in true emergency situations

32 Respondents San Dimas and Patel did not obtain the original prescriptions signed

and dated in ink by the prescriber within seven days of filling the prescriptions The investigator

asked Respondents San Dimas and Patel to show her the original prescriptions but they could not

produce these documents

33 The inspector found a folder in the pharmacy containing many labels bearing the

words balance owed The inspector determined that these labels showed the quantity of

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medications still owed to patients on prescriptions that they had purchased from Respondent San

Dimas

34 Respondent Patel did not reverse the insurance claims she submitted for the

prescriptions where there was a balanced owed She also did not resubmit the claims for the

actual quantity of medication the pharmacy had provided to the patient Respondent Patel instead

waited for the patients who were owed additional medication to return to the pharmacy to request

the balance owed

35 From approximately September 24 2010 to August 152012 Respondents San

Dimas and Patel failed to completely fill 178 prescriptions and submit invoices to the insurance

companies for the amount of medication the pharmacy actually dispensed None of the patients

for these 178 prescriptions returned to the pharmacy and claimed their owed balances of

medication

2013 Investigation

36 On or about August 282013 Board inspectors (inspectors) conducted another

inspection at Respondent San Dimas

37 One of the inspectors found that Respondents had expired and non-expired bulk stock

medications intermixed on their active use medication shelving The inspector reviewed

Respondents completed compounding log sheets and found that several of the expired products

had been used to prepare compounded products with an assigned beyond use date greater than the

expiration date of at least one of the ingredients

38 The inspectors notiCed that a number of entries on Respondents compounding log

sheets were incomplete because Respondents failed to include necessary documentation

including the ingredient lot numbers manufacturers name andor ingredient expiration dates

Respondents failed to include the generic active ingredients on many of the labels on the

compounded drugs

39 The inspectors noticed that Respondents had a number of containers labeled sample I cream on the premises Respondents said that occasionally when their customers had to wait

for approval from their insurance companies for payment for a compound drug Respondents

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staff members would ask the patients physicians for permission to provide sample creams

during the interim period

40 One of Respondents pharmacy technicians would speak with patients physicians

offices to ask for approval to give patients sample cream The technicians would write down

the order for the sample cream on the original prescription copy The sample creams contained

dangerous drugs The orders were not valid prescriptions because a pharmacist did not orally

receive them and a physician did not handwrite or transmit them The approved prescriptions

were incomplete because they did not include the name of the physicians offices staff member

who authorized the prescription the list of ingredients the quantity or length of time directions

or the initials of Respondents staff member who received the oral prescription

41 Many of the compound prescriptions were on pre-printed prescription forms provided

by Respondents to the patients physicians offices Respondents preprinted prescription forms

which included controlled substance prescriptions were multiple check-off prescription blank

forms Three ofthe prescription formulas on the preprinted prescription forms contained

ketamine a controlled substance Prescriptions for controlled substance are required to be

written on a secure blank prescription form faxed with a physicians signature and date or orally

prescribed by the patients physician to the pharmacist Respondents controlled substance preshy

printed prescriptions were not on secure blank prescription forms or orally received by

Respondents pharmacists

42 On one of the physician-approved prescriptions for the Schedule lii controlled

substance ketamine the physician authorized 11 refills and did not record the date on which she

approved the prescription

43 Respondents failed to identify ketamine as a Schedule lii controlled substance in their

compounding software program Due to this oversight Respondents did not record prescriptions

using or incorporating ketamine as controlled substance prescriptions Respondents did not

ensure that prescriptions using or incorporating ketamine were written on secure blank

prescription forms or that oral prescriptions using or incorporating ketamine were only received

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by the pharmacist Respondents did not report prescriptions using or incorporating ketamine to

the Controlled Substance Utilization Review and Evaluation System (CURES)

44 On or about December 17 2013 Respondents dispensed a prescription for T3fT4

Mixture C 2080 mg capsules A qualitative analysis report taken on or about February 21 2014

revealed that the T4 (Levothyroxine Sodium) component of the compounded drug was sub-potent

because the T 4 was 735 of the expected potency

FIRST CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(l))

45 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in ink by

the prescribers (Health amp Saf Codesect 11164 subd (a)(1)) The circumstances are further

explained in paragraphs 30 to 32 above

SECOND CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

46 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action

because it filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Code sect 11167) Respondent San Dimas also failed to obtain the

original prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

THIRD CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Prof Codesect 4301 subd (f))

47 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging in unprofessional conduct because it committed acts involving fraud (Bus amp Prof

Codesect 4301 subd (f)) Respondent San Dimas left a balance of medications owing on 178 of

the prescriptions it sold The circumstances are further explained in paragraphs 34 to 35 above

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FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

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SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

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and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

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THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

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SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

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(E) A legible clear notice ofthe condition or purpose for which the drug is being

prescribed if requested by the patient or patients

(F) If in writing signed by the prescriber issuing the order or the certified nurse-midwife

nurse practitioner physician assistant or naturopathic doctor who issues a drug order pursuant to

Section 274651 28361 35021 or 36405 respectively or the pharmacist who issues a drug

order pursuant to Section 40521 40522 or 40526

9 S~ction 4051 of the Code states in pertinent part

(a) Except as otherwise provided in this chapter it is unlawful for any person to

manufacture compound furnish sell or dispense a dangerous drug or dangerous device or to

dispense or compound a prescription pursuant to Section 4040 of a prescriber unless he or she is a

pharmacist under this chapter

10 Section 4301 ofthe Code states in pertinent part

The board shall take action against any holder of a license who is guilty of unprofessional

conduct or whose license has been procured by fraud or misrepresentation or issued by mistake

Unprofessional conduct shall include but is not limited to any of the following

(f) The commission of any act involving moral turpitude dishonesty fraud deceit or

corruption whether the act is committed in the course of relations as a licensee or otherwise and

whether the act is a felony or misdemeanor or not

(g) Knowingly making or signing any certificate or other document that falsely represents

the existence or nonexistence of a state of facts

II Section 4307 of the Code states

(a) Any person who has been denied a license or whose license has been revoked or is

under suspension or who has failed to renew his or her license while it was under suspension or

who has been a manager administrator owner member officer director associate or partner of

any partnership corporation firm or association whose application for a license has been denied

or revoked is under suspension or has been placed on probation and while acting as the manager

administrator owner member officer director associate or partner had knowledge of or

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knowingly participated in any conduct for which the license was denied revoked suspended or

placed on probation shall be prohibited from serving as a manager administrator owner

member officer director associate or partner of a licensee as follows

()Where a probationary license is issued or where an existing license is placed on

probation this prohibition shall remain in effect for a period not to exceed five years

(2) Where the license is denied or revoked the prohibition shall continue until the license

is issued or reinstated

(b) Manager administrator owner member officer director associate or partner as

used in this section and Section 4308 may refer to a pharmacist or to any other person who

serves in that capacity in or for a licensee

(c) The provisions of subdivision (a) may be alleged in any pleading filed pursuant to

Chapter 5 (commencing with Section 11500) of Part I of Division 3 of the Government Code

However no order may be issued in that case except as to a person who is named in the caption

as to whom the pleading alleges the applicability of this section and where the person has been

given notice of the proceeding as required by Chapter 5 (commencing with Section 11500) of

Part I of Division 3 of the Government Code The authority to proceed as provided by this

subdivision shall be in addition to the boards authority to proceed under Section 4339 or any

other provision of law

12 Section 11164 of the Health and Safety Code states in pertinent part

Except as provided in Section 11167 no person shall prescribe a controlled substance nor

shall any person fill compound or dispense a prescription for a controlled substance unless it

complies with the requirements of this section

(a) Each prescription for a controlled substance classified in Schedule II Ill IV or V

except as authorized by subdivision (b) shall be made on a controlled substance prescription

form as specified in Section 111621 and shall meet the following requirements

(1) The prescription shall be signed and dated by the prescriber in ink and shall contain the

prescribers address and telephone number the name of the ultimate user or research subject or

contact information as determined by the Secretary of the United States Department of Health and

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Human Services refill information such as the number of refills ordered and whether the

prescription is a first-time request or a refill and the name quantity strength and directions for

use of the controlled substance prescribed

13 Section 11167 of the Health and Safety Code states

Notwithstanding subdivision (a) of Section 11164 in an emergency where failure to issue

a prescription may result in loss oflife or intense suffering an order for a controlled substance

may be dispensed on an oral order an electronic data transmission order or a written order not

made on a controlled substance form as specified in Section 111621 subject to all of the

following requirements

(a) The order contains all information required by subdivision (a) of Section 11164

(b) Any written order is signed and dated by the prescriber in ink and the pharmacy

reduces any oral or electronic data transmission order to hard copy form prior to dispensing the

controlled substance

(c) The prescriber provides a written prescription on a controlled substance prescription

form that meets the requirements of Section 111621 by the seventh day following the

transmission of the initial order a postmark by the seventh day following transmission of the

initial order shall constitute compliance

(d) If the prescriber fails to comply with subdivision (c) the pharmacy shall so notifY the

Department of Justice in writing within 144 hours of the prescribers failure to do so and shall

make and retain a hard copy readily retrievable record of the prescription including the date and

method of notification of the Department of Justice

(e) This section shall become operative on January I 2005

14 Section 11200 of the Health and Safety Code states in pertinent part

(b) No prescription for a Schedule lii or IV substance may be refilled more than five times

and in an amount for all refills of that prescription taken together exceeding a 120-day supply

15 California Code of Regulations title 16 section 1717 states in pertinent part

Promptly upon receipt of an orally transmitted prescription the pharmacist shall reduce it

to writing and initial it and identity it as an orally transmitted prescription If the prescription is

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then dispensed by another pharmacist the dispensing pharmacist shall also initial the prescription

to identify him or herself All orally transmitted prescriptions shall be received and transcribed by

a pharmacist prior to compounding filling dispensing or furnishing Chart orders as defined in

section 4019 of the Business and Professions Code are not subject to the provisions of this

subsection

16 California Code of Regulations title 16 section 17352 states in pertinent part

(f) The pharmacist performing or supervising compounding is responsible for the integrity

potency quality and labeled strength of a compounded drug product until it is dispensed

(h) Every compounded drug product shall be given an expiration date representing the date

beyond which in the professional judgment of the pharmacist performing or supervising the

compounding it should not be used This beyond use date of the compounded drug product

shall not exceed 180 days from preparation or the shortest expiration date of any component in

the compounded drug product unless a longer date is supported by stability studies of finished

drugs or compounded drug products using the same components and packaging Shorter dating

than set forth in this subsection may be used if it is deemed appropriate in the professional

judgment of the responsible pharmacist

17 California Code of Regulations title 16 section 17353 states in pertinent part

(a) For each compounded drug product the pharmacy records shall include

(I) The master formula record

(2) The date the drug product was compounded

(3) The identity of the pharmacy personnel who compounded the drug product

(4) The identity of the pharmacist reviewing the final drug product

(5) The quantity of each component used in compounding the drug product

~(6) The manufacturer expiration date and lot number of each component lfthe

manufacturer name is demonstrably unavailable the name of the supplier may be substituted

Exempt from the requirements in this paragraph are sterile products compounded on a one-time

basis for administration within seventy-two (72) hours and stored in accordance with standards

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for Redispensed CSPS found in Chapter 797 of the United States Pharmacopeia- National

Formulary (USP-NF) (35th Revision Effective May I 2012) hereby incorporated by reference

to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code

(7) A pharmacy assigned reference or lot number for the compounded drug product

(8) The expiration date of the final compounded drug product

(9) The quantity or amount of drug product compounded

18 Code of Federal Regulations title 21 section 130404 states in pertinent part

(f) Each registered manufacturer distributor importer exporter narcotic treatment

program and compounder for narcotic treatment program shall maintain inventories and records

of controlled substances as follows

(2) Inventories and records of controlled substances listed in Schedules III IV and V shall

be maintained either separately from all other records of the registrant or in such form that the

information required is readily retrievable from the ordinary business records of the registrant

CONTROLLED SUBSTANCES

19 Section 4021 of the Code states

Controlled substance means any substance listed in Chapter 2 (commencing with Section

11 053) of Division 10 of the Health and Safety Code

20 Oxycodone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(M)

21 Morphine is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(L)

22 Vyvanase is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (d)2)

23 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)(14)

24 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)14)

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25 Ketamine is a Schedule III controlled substance as designated by Health and Safety

Code section II 056 subdivision (g)

COST RECOVERY

26 Code section 1253 states in part that the Board may request the administrative law

judge to direct a licentiate found to have committed a violation or violations of the licensing act

to pay a sum not to exceed the reasonable costs of the investigation and enforcement of the case

FACTUALSTATEMENT

27 From about January 1 2008 to the present Respondent San Dimas Pharmacy amp

Compounding Center (Respondent San Dimas) has been operating as a pharmacy in Bakersfield

California From about January 7 2008 to the present Kalpana Patel (Respondent Patel) has

been the pharmacist-in-charge (PIC) at Respondent San Dimas

2012 Complaint and Investigation

28 On or about May 9 2012 a private individual submitted an online complaint to the

Board alleging that Respondent San Dimas was committing various license violations including

filling faxed copies of prescriptions in non-emergency situations and failing to obtain the original

hard copies of the prescriptions until much later and sometimes submitting invoices to insurance

companies for larger quantities of medication than the pharmacy actually dispensed to the

insurance companies customers and never giving the customers their remaining balance of

medication

29 On or about August 292012 in response to the complaint a Board inspector

(inspector) conducted an inspection at Respondent San Dimas

30 While at the pharmacy the inspector found five prescriptions for Schedule II

controlled substances that the pharmacy had filled even though the prescriptions were not signed

and dated in ink by the original prescriber The specifics ofthe five prescriptions are as follows

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a A prescription dated August 24 2012 for oxycodone The prescription was a

photocopy of the original prescription The prescription was not signed and dated in ink by the

prescriber

b A prescription dated March 15 2012 for methadone The prescription was on a

faxed refill authorization request form The prescription was not signed and dated in ink by the

prescriber

c A prescription dated March 172012 for morphine The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

d A prescription dated April 6 2012 for oxycodone The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

e A prescription dated May 162012 for Vyvanse The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

31 Respondent Patel told the inspector that she filled these five prescriptions for

Schedule II controlled substances without the required signatures because there was a possibility

the patients would run out of their medications while their doctors offices were closed The

inspector informed Respondent Patel that she could not provide Schedule II controlled substances

without a properly signed prescription unless there was a true emergency situation meaning that

not providing the medication would result in harm to the patient The inspector did not believe

that the patients with the five prescriptions in question had been in true emergency situations

32 Respondents San Dimas and Patel did not obtain the original prescriptions signed

and dated in ink by the prescriber within seven days of filling the prescriptions The investigator

asked Respondents San Dimas and Patel to show her the original prescriptions but they could not

produce these documents

33 The inspector found a folder in the pharmacy containing many labels bearing the

words balance owed The inspector determined that these labels showed the quantity of

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medications still owed to patients on prescriptions that they had purchased from Respondent San

Dimas

34 Respondent Patel did not reverse the insurance claims she submitted for the

prescriptions where there was a balanced owed She also did not resubmit the claims for the

actual quantity of medication the pharmacy had provided to the patient Respondent Patel instead

waited for the patients who were owed additional medication to return to the pharmacy to request

the balance owed

35 From approximately September 24 2010 to August 152012 Respondents San

Dimas and Patel failed to completely fill 178 prescriptions and submit invoices to the insurance

companies for the amount of medication the pharmacy actually dispensed None of the patients

for these 178 prescriptions returned to the pharmacy and claimed their owed balances of

medication

2013 Investigation

36 On or about August 282013 Board inspectors (inspectors) conducted another

inspection at Respondent San Dimas

37 One of the inspectors found that Respondents had expired and non-expired bulk stock

medications intermixed on their active use medication shelving The inspector reviewed

Respondents completed compounding log sheets and found that several of the expired products

had been used to prepare compounded products with an assigned beyond use date greater than the

expiration date of at least one of the ingredients

38 The inspectors notiCed that a number of entries on Respondents compounding log

sheets were incomplete because Respondents failed to include necessary documentation

including the ingredient lot numbers manufacturers name andor ingredient expiration dates

Respondents failed to include the generic active ingredients on many of the labels on the

compounded drugs

39 The inspectors noticed that Respondents had a number of containers labeled sample I cream on the premises Respondents said that occasionally when their customers had to wait

for approval from their insurance companies for payment for a compound drug Respondents

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staff members would ask the patients physicians for permission to provide sample creams

during the interim period

40 One of Respondents pharmacy technicians would speak with patients physicians

offices to ask for approval to give patients sample cream The technicians would write down

the order for the sample cream on the original prescription copy The sample creams contained

dangerous drugs The orders were not valid prescriptions because a pharmacist did not orally

receive them and a physician did not handwrite or transmit them The approved prescriptions

were incomplete because they did not include the name of the physicians offices staff member

who authorized the prescription the list of ingredients the quantity or length of time directions

or the initials of Respondents staff member who received the oral prescription

41 Many of the compound prescriptions were on pre-printed prescription forms provided

by Respondents to the patients physicians offices Respondents preprinted prescription forms

which included controlled substance prescriptions were multiple check-off prescription blank

forms Three ofthe prescription formulas on the preprinted prescription forms contained

ketamine a controlled substance Prescriptions for controlled substance are required to be

written on a secure blank prescription form faxed with a physicians signature and date or orally

prescribed by the patients physician to the pharmacist Respondents controlled substance preshy

printed prescriptions were not on secure blank prescription forms or orally received by

Respondents pharmacists

42 On one of the physician-approved prescriptions for the Schedule lii controlled

substance ketamine the physician authorized 11 refills and did not record the date on which she

approved the prescription

43 Respondents failed to identify ketamine as a Schedule lii controlled substance in their

compounding software program Due to this oversight Respondents did not record prescriptions

using or incorporating ketamine as controlled substance prescriptions Respondents did not

ensure that prescriptions using or incorporating ketamine were written on secure blank

prescription forms or that oral prescriptions using or incorporating ketamine were only received

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by the pharmacist Respondents did not report prescriptions using or incorporating ketamine to

the Controlled Substance Utilization Review and Evaluation System (CURES)

44 On or about December 17 2013 Respondents dispensed a prescription for T3fT4

Mixture C 2080 mg capsules A qualitative analysis report taken on or about February 21 2014

revealed that the T4 (Levothyroxine Sodium) component of the compounded drug was sub-potent

because the T 4 was 735 of the expected potency

FIRST CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(l))

45 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in ink by

the prescribers (Health amp Saf Codesect 11164 subd (a)(1)) The circumstances are further

explained in paragraphs 30 to 32 above

SECOND CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

46 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action

because it filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Code sect 11167) Respondent San Dimas also failed to obtain the

original prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

THIRD CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Prof Codesect 4301 subd (f))

47 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging in unprofessional conduct because it committed acts involving fraud (Bus amp Prof

Codesect 4301 subd (f)) Respondent San Dimas left a balance of medications owing on 178 of

the prescriptions it sold The circumstances are further explained in paragraphs 34 to 35 above

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FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

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SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

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and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

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THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

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SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

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knowingly participated in any conduct for which the license was denied revoked suspended or

placed on probation shall be prohibited from serving as a manager administrator owner

member officer director associate or partner of a licensee as follows

()Where a probationary license is issued or where an existing license is placed on

probation this prohibition shall remain in effect for a period not to exceed five years

(2) Where the license is denied or revoked the prohibition shall continue until the license

is issued or reinstated

(b) Manager administrator owner member officer director associate or partner as

used in this section and Section 4308 may refer to a pharmacist or to any other person who

serves in that capacity in or for a licensee

(c) The provisions of subdivision (a) may be alleged in any pleading filed pursuant to

Chapter 5 (commencing with Section 11500) of Part I of Division 3 of the Government Code

However no order may be issued in that case except as to a person who is named in the caption

as to whom the pleading alleges the applicability of this section and where the person has been

given notice of the proceeding as required by Chapter 5 (commencing with Section 11500) of

Part I of Division 3 of the Government Code The authority to proceed as provided by this

subdivision shall be in addition to the boards authority to proceed under Section 4339 or any

other provision of law

12 Section 11164 of the Health and Safety Code states in pertinent part

Except as provided in Section 11167 no person shall prescribe a controlled substance nor

shall any person fill compound or dispense a prescription for a controlled substance unless it

complies with the requirements of this section

(a) Each prescription for a controlled substance classified in Schedule II Ill IV or V

except as authorized by subdivision (b) shall be made on a controlled substance prescription

form as specified in Section 111621 and shall meet the following requirements

(1) The prescription shall be signed and dated by the prescriber in ink and shall contain the

prescribers address and telephone number the name of the ultimate user or research subject or

contact information as determined by the Secretary of the United States Department of Health and

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Human Services refill information such as the number of refills ordered and whether the

prescription is a first-time request or a refill and the name quantity strength and directions for

use of the controlled substance prescribed

13 Section 11167 of the Health and Safety Code states

Notwithstanding subdivision (a) of Section 11164 in an emergency where failure to issue

a prescription may result in loss oflife or intense suffering an order for a controlled substance

may be dispensed on an oral order an electronic data transmission order or a written order not

made on a controlled substance form as specified in Section 111621 subject to all of the

following requirements

(a) The order contains all information required by subdivision (a) of Section 11164

(b) Any written order is signed and dated by the prescriber in ink and the pharmacy

reduces any oral or electronic data transmission order to hard copy form prior to dispensing the

controlled substance

(c) The prescriber provides a written prescription on a controlled substance prescription

form that meets the requirements of Section 111621 by the seventh day following the

transmission of the initial order a postmark by the seventh day following transmission of the

initial order shall constitute compliance

(d) If the prescriber fails to comply with subdivision (c) the pharmacy shall so notifY the

Department of Justice in writing within 144 hours of the prescribers failure to do so and shall

make and retain a hard copy readily retrievable record of the prescription including the date and

method of notification of the Department of Justice

(e) This section shall become operative on January I 2005

14 Section 11200 of the Health and Safety Code states in pertinent part

(b) No prescription for a Schedule lii or IV substance may be refilled more than five times

and in an amount for all refills of that prescription taken together exceeding a 120-day supply

15 California Code of Regulations title 16 section 1717 states in pertinent part

Promptly upon receipt of an orally transmitted prescription the pharmacist shall reduce it

to writing and initial it and identity it as an orally transmitted prescription If the prescription is

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then dispensed by another pharmacist the dispensing pharmacist shall also initial the prescription

to identify him or herself All orally transmitted prescriptions shall be received and transcribed by

a pharmacist prior to compounding filling dispensing or furnishing Chart orders as defined in

section 4019 of the Business and Professions Code are not subject to the provisions of this

subsection

16 California Code of Regulations title 16 section 17352 states in pertinent part

(f) The pharmacist performing or supervising compounding is responsible for the integrity

potency quality and labeled strength of a compounded drug product until it is dispensed

(h) Every compounded drug product shall be given an expiration date representing the date

beyond which in the professional judgment of the pharmacist performing or supervising the

compounding it should not be used This beyond use date of the compounded drug product

shall not exceed 180 days from preparation or the shortest expiration date of any component in

the compounded drug product unless a longer date is supported by stability studies of finished

drugs or compounded drug products using the same components and packaging Shorter dating

than set forth in this subsection may be used if it is deemed appropriate in the professional

judgment of the responsible pharmacist

17 California Code of Regulations title 16 section 17353 states in pertinent part

(a) For each compounded drug product the pharmacy records shall include

(I) The master formula record

(2) The date the drug product was compounded

(3) The identity of the pharmacy personnel who compounded the drug product

(4) The identity of the pharmacist reviewing the final drug product

(5) The quantity of each component used in compounding the drug product

~(6) The manufacturer expiration date and lot number of each component lfthe

manufacturer name is demonstrably unavailable the name of the supplier may be substituted

Exempt from the requirements in this paragraph are sterile products compounded on a one-time

basis for administration within seventy-two (72) hours and stored in accordance with standards

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for Redispensed CSPS found in Chapter 797 of the United States Pharmacopeia- National

Formulary (USP-NF) (35th Revision Effective May I 2012) hereby incorporated by reference

to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code

(7) A pharmacy assigned reference or lot number for the compounded drug product

(8) The expiration date of the final compounded drug product

(9) The quantity or amount of drug product compounded

18 Code of Federal Regulations title 21 section 130404 states in pertinent part

(f) Each registered manufacturer distributor importer exporter narcotic treatment

program and compounder for narcotic treatment program shall maintain inventories and records

of controlled substances as follows

(2) Inventories and records of controlled substances listed in Schedules III IV and V shall

be maintained either separately from all other records of the registrant or in such form that the

information required is readily retrievable from the ordinary business records of the registrant

CONTROLLED SUBSTANCES

19 Section 4021 of the Code states

Controlled substance means any substance listed in Chapter 2 (commencing with Section

11 053) of Division 10 of the Health and Safety Code

20 Oxycodone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(M)

21 Morphine is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(L)

22 Vyvanase is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (d)2)

23 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)(14)

24 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)14)

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25 Ketamine is a Schedule III controlled substance as designated by Health and Safety

Code section II 056 subdivision (g)

COST RECOVERY

26 Code section 1253 states in part that the Board may request the administrative law

judge to direct a licentiate found to have committed a violation or violations of the licensing act

to pay a sum not to exceed the reasonable costs of the investigation and enforcement of the case

FACTUALSTATEMENT

27 From about January 1 2008 to the present Respondent San Dimas Pharmacy amp

Compounding Center (Respondent San Dimas) has been operating as a pharmacy in Bakersfield

California From about January 7 2008 to the present Kalpana Patel (Respondent Patel) has

been the pharmacist-in-charge (PIC) at Respondent San Dimas

2012 Complaint and Investigation

28 On or about May 9 2012 a private individual submitted an online complaint to the

Board alleging that Respondent San Dimas was committing various license violations including

filling faxed copies of prescriptions in non-emergency situations and failing to obtain the original

hard copies of the prescriptions until much later and sometimes submitting invoices to insurance

companies for larger quantities of medication than the pharmacy actually dispensed to the

insurance companies customers and never giving the customers their remaining balance of

medication

29 On or about August 292012 in response to the complaint a Board inspector

(inspector) conducted an inspection at Respondent San Dimas

30 While at the pharmacy the inspector found five prescriptions for Schedule II

controlled substances that the pharmacy had filled even though the prescriptions were not signed

and dated in ink by the original prescriber The specifics ofthe five prescriptions are as follows

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a A prescription dated August 24 2012 for oxycodone The prescription was a

photocopy of the original prescription The prescription was not signed and dated in ink by the

prescriber

b A prescription dated March 15 2012 for methadone The prescription was on a

faxed refill authorization request form The prescription was not signed and dated in ink by the

prescriber

c A prescription dated March 172012 for morphine The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

d A prescription dated April 6 2012 for oxycodone The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

e A prescription dated May 162012 for Vyvanse The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

31 Respondent Patel told the inspector that she filled these five prescriptions for

Schedule II controlled substances without the required signatures because there was a possibility

the patients would run out of their medications while their doctors offices were closed The

inspector informed Respondent Patel that she could not provide Schedule II controlled substances

without a properly signed prescription unless there was a true emergency situation meaning that

not providing the medication would result in harm to the patient The inspector did not believe

that the patients with the five prescriptions in question had been in true emergency situations

32 Respondents San Dimas and Patel did not obtain the original prescriptions signed

and dated in ink by the prescriber within seven days of filling the prescriptions The investigator

asked Respondents San Dimas and Patel to show her the original prescriptions but they could not

produce these documents

33 The inspector found a folder in the pharmacy containing many labels bearing the

words balance owed The inspector determined that these labels showed the quantity of

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medications still owed to patients on prescriptions that they had purchased from Respondent San

Dimas

34 Respondent Patel did not reverse the insurance claims she submitted for the

prescriptions where there was a balanced owed She also did not resubmit the claims for the

actual quantity of medication the pharmacy had provided to the patient Respondent Patel instead

waited for the patients who were owed additional medication to return to the pharmacy to request

the balance owed

35 From approximately September 24 2010 to August 152012 Respondents San

Dimas and Patel failed to completely fill 178 prescriptions and submit invoices to the insurance

companies for the amount of medication the pharmacy actually dispensed None of the patients

for these 178 prescriptions returned to the pharmacy and claimed their owed balances of

medication

2013 Investigation

36 On or about August 282013 Board inspectors (inspectors) conducted another

inspection at Respondent San Dimas

37 One of the inspectors found that Respondents had expired and non-expired bulk stock

medications intermixed on their active use medication shelving The inspector reviewed

Respondents completed compounding log sheets and found that several of the expired products

had been used to prepare compounded products with an assigned beyond use date greater than the

expiration date of at least one of the ingredients

38 The inspectors notiCed that a number of entries on Respondents compounding log

sheets were incomplete because Respondents failed to include necessary documentation

including the ingredient lot numbers manufacturers name andor ingredient expiration dates

Respondents failed to include the generic active ingredients on many of the labels on the

compounded drugs

39 The inspectors noticed that Respondents had a number of containers labeled sample I cream on the premises Respondents said that occasionally when their customers had to wait

for approval from their insurance companies for payment for a compound drug Respondents

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staff members would ask the patients physicians for permission to provide sample creams

during the interim period

40 One of Respondents pharmacy technicians would speak with patients physicians

offices to ask for approval to give patients sample cream The technicians would write down

the order for the sample cream on the original prescription copy The sample creams contained

dangerous drugs The orders were not valid prescriptions because a pharmacist did not orally

receive them and a physician did not handwrite or transmit them The approved prescriptions

were incomplete because they did not include the name of the physicians offices staff member

who authorized the prescription the list of ingredients the quantity or length of time directions

or the initials of Respondents staff member who received the oral prescription

41 Many of the compound prescriptions were on pre-printed prescription forms provided

by Respondents to the patients physicians offices Respondents preprinted prescription forms

which included controlled substance prescriptions were multiple check-off prescription blank

forms Three ofthe prescription formulas on the preprinted prescription forms contained

ketamine a controlled substance Prescriptions for controlled substance are required to be

written on a secure blank prescription form faxed with a physicians signature and date or orally

prescribed by the patients physician to the pharmacist Respondents controlled substance preshy

printed prescriptions were not on secure blank prescription forms or orally received by

Respondents pharmacists

42 On one of the physician-approved prescriptions for the Schedule lii controlled

substance ketamine the physician authorized 11 refills and did not record the date on which she

approved the prescription

43 Respondents failed to identify ketamine as a Schedule lii controlled substance in their

compounding software program Due to this oversight Respondents did not record prescriptions

using or incorporating ketamine as controlled substance prescriptions Respondents did not

ensure that prescriptions using or incorporating ketamine were written on secure blank

prescription forms or that oral prescriptions using or incorporating ketamine were only received

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by the pharmacist Respondents did not report prescriptions using or incorporating ketamine to

the Controlled Substance Utilization Review and Evaluation System (CURES)

44 On or about December 17 2013 Respondents dispensed a prescription for T3fT4

Mixture C 2080 mg capsules A qualitative analysis report taken on or about February 21 2014

revealed that the T4 (Levothyroxine Sodium) component of the compounded drug was sub-potent

because the T 4 was 735 of the expected potency

FIRST CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(l))

45 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in ink by

the prescribers (Health amp Saf Codesect 11164 subd (a)(1)) The circumstances are further

explained in paragraphs 30 to 32 above

SECOND CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

46 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action

because it filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Code sect 11167) Respondent San Dimas also failed to obtain the

original prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

THIRD CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Prof Codesect 4301 subd (f))

47 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging in unprofessional conduct because it committed acts involving fraud (Bus amp Prof

Codesect 4301 subd (f)) Respondent San Dimas left a balance of medications owing on 178 of

the prescriptions it sold The circumstances are further explained in paragraphs 34 to 35 above

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FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

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SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

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and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

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THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

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SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

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Human Services refill information such as the number of refills ordered and whether the

prescription is a first-time request or a refill and the name quantity strength and directions for

use of the controlled substance prescribed

13 Section 11167 of the Health and Safety Code states

Notwithstanding subdivision (a) of Section 11164 in an emergency where failure to issue

a prescription may result in loss oflife or intense suffering an order for a controlled substance

may be dispensed on an oral order an electronic data transmission order or a written order not

made on a controlled substance form as specified in Section 111621 subject to all of the

following requirements

(a) The order contains all information required by subdivision (a) of Section 11164

(b) Any written order is signed and dated by the prescriber in ink and the pharmacy

reduces any oral or electronic data transmission order to hard copy form prior to dispensing the

controlled substance

(c) The prescriber provides a written prescription on a controlled substance prescription

form that meets the requirements of Section 111621 by the seventh day following the

transmission of the initial order a postmark by the seventh day following transmission of the

initial order shall constitute compliance

(d) If the prescriber fails to comply with subdivision (c) the pharmacy shall so notifY the

Department of Justice in writing within 144 hours of the prescribers failure to do so and shall

make and retain a hard copy readily retrievable record of the prescription including the date and

method of notification of the Department of Justice

(e) This section shall become operative on January I 2005

14 Section 11200 of the Health and Safety Code states in pertinent part

(b) No prescription for a Schedule lii or IV substance may be refilled more than five times

and in an amount for all refills of that prescription taken together exceeding a 120-day supply

15 California Code of Regulations title 16 section 1717 states in pertinent part

Promptly upon receipt of an orally transmitted prescription the pharmacist shall reduce it

to writing and initial it and identity it as an orally transmitted prescription If the prescription is

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then dispensed by another pharmacist the dispensing pharmacist shall also initial the prescription

to identify him or herself All orally transmitted prescriptions shall be received and transcribed by

a pharmacist prior to compounding filling dispensing or furnishing Chart orders as defined in

section 4019 of the Business and Professions Code are not subject to the provisions of this

subsection

16 California Code of Regulations title 16 section 17352 states in pertinent part

(f) The pharmacist performing or supervising compounding is responsible for the integrity

potency quality and labeled strength of a compounded drug product until it is dispensed

(h) Every compounded drug product shall be given an expiration date representing the date

beyond which in the professional judgment of the pharmacist performing or supervising the

compounding it should not be used This beyond use date of the compounded drug product

shall not exceed 180 days from preparation or the shortest expiration date of any component in

the compounded drug product unless a longer date is supported by stability studies of finished

drugs or compounded drug products using the same components and packaging Shorter dating

than set forth in this subsection may be used if it is deemed appropriate in the professional

judgment of the responsible pharmacist

17 California Code of Regulations title 16 section 17353 states in pertinent part

(a) For each compounded drug product the pharmacy records shall include

(I) The master formula record

(2) The date the drug product was compounded

(3) The identity of the pharmacy personnel who compounded the drug product

(4) The identity of the pharmacist reviewing the final drug product

(5) The quantity of each component used in compounding the drug product

~(6) The manufacturer expiration date and lot number of each component lfthe

manufacturer name is demonstrably unavailable the name of the supplier may be substituted

Exempt from the requirements in this paragraph are sterile products compounded on a one-time

basis for administration within seventy-two (72) hours and stored in accordance with standards

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for Redispensed CSPS found in Chapter 797 of the United States Pharmacopeia- National

Formulary (USP-NF) (35th Revision Effective May I 2012) hereby incorporated by reference

to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code

(7) A pharmacy assigned reference or lot number for the compounded drug product

(8) The expiration date of the final compounded drug product

(9) The quantity or amount of drug product compounded

18 Code of Federal Regulations title 21 section 130404 states in pertinent part

(f) Each registered manufacturer distributor importer exporter narcotic treatment

program and compounder for narcotic treatment program shall maintain inventories and records

of controlled substances as follows

(2) Inventories and records of controlled substances listed in Schedules III IV and V shall

be maintained either separately from all other records of the registrant or in such form that the

information required is readily retrievable from the ordinary business records of the registrant

CONTROLLED SUBSTANCES

19 Section 4021 of the Code states

Controlled substance means any substance listed in Chapter 2 (commencing with Section

11 053) of Division 10 of the Health and Safety Code

20 Oxycodone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(M)

21 Morphine is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(L)

22 Vyvanase is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (d)2)

23 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)(14)

24 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)14)

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25 Ketamine is a Schedule III controlled substance as designated by Health and Safety

Code section II 056 subdivision (g)

COST RECOVERY

26 Code section 1253 states in part that the Board may request the administrative law

judge to direct a licentiate found to have committed a violation or violations of the licensing act

to pay a sum not to exceed the reasonable costs of the investigation and enforcement of the case

FACTUALSTATEMENT

27 From about January 1 2008 to the present Respondent San Dimas Pharmacy amp

Compounding Center (Respondent San Dimas) has been operating as a pharmacy in Bakersfield

California From about January 7 2008 to the present Kalpana Patel (Respondent Patel) has

been the pharmacist-in-charge (PIC) at Respondent San Dimas

2012 Complaint and Investigation

28 On or about May 9 2012 a private individual submitted an online complaint to the

Board alleging that Respondent San Dimas was committing various license violations including

filling faxed copies of prescriptions in non-emergency situations and failing to obtain the original

hard copies of the prescriptions until much later and sometimes submitting invoices to insurance

companies for larger quantities of medication than the pharmacy actually dispensed to the

insurance companies customers and never giving the customers their remaining balance of

medication

29 On or about August 292012 in response to the complaint a Board inspector

(inspector) conducted an inspection at Respondent San Dimas

30 While at the pharmacy the inspector found five prescriptions for Schedule II

controlled substances that the pharmacy had filled even though the prescriptions were not signed

and dated in ink by the original prescriber The specifics ofthe five prescriptions are as follows

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a A prescription dated August 24 2012 for oxycodone The prescription was a

photocopy of the original prescription The prescription was not signed and dated in ink by the

prescriber

b A prescription dated March 15 2012 for methadone The prescription was on a

faxed refill authorization request form The prescription was not signed and dated in ink by the

prescriber

c A prescription dated March 172012 for morphine The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

d A prescription dated April 6 2012 for oxycodone The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

e A prescription dated May 162012 for Vyvanse The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

31 Respondent Patel told the inspector that she filled these five prescriptions for

Schedule II controlled substances without the required signatures because there was a possibility

the patients would run out of their medications while their doctors offices were closed The

inspector informed Respondent Patel that she could not provide Schedule II controlled substances

without a properly signed prescription unless there was a true emergency situation meaning that

not providing the medication would result in harm to the patient The inspector did not believe

that the patients with the five prescriptions in question had been in true emergency situations

32 Respondents San Dimas and Patel did not obtain the original prescriptions signed

and dated in ink by the prescriber within seven days of filling the prescriptions The investigator

asked Respondents San Dimas and Patel to show her the original prescriptions but they could not

produce these documents

33 The inspector found a folder in the pharmacy containing many labels bearing the

words balance owed The inspector determined that these labels showed the quantity of

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medications still owed to patients on prescriptions that they had purchased from Respondent San

Dimas

34 Respondent Patel did not reverse the insurance claims she submitted for the

prescriptions where there was a balanced owed She also did not resubmit the claims for the

actual quantity of medication the pharmacy had provided to the patient Respondent Patel instead

waited for the patients who were owed additional medication to return to the pharmacy to request

the balance owed

35 From approximately September 24 2010 to August 152012 Respondents San

Dimas and Patel failed to completely fill 178 prescriptions and submit invoices to the insurance

companies for the amount of medication the pharmacy actually dispensed None of the patients

for these 178 prescriptions returned to the pharmacy and claimed their owed balances of

medication

2013 Investigation

36 On or about August 282013 Board inspectors (inspectors) conducted another

inspection at Respondent San Dimas

37 One of the inspectors found that Respondents had expired and non-expired bulk stock

medications intermixed on their active use medication shelving The inspector reviewed

Respondents completed compounding log sheets and found that several of the expired products

had been used to prepare compounded products with an assigned beyond use date greater than the

expiration date of at least one of the ingredients

38 The inspectors notiCed that a number of entries on Respondents compounding log

sheets were incomplete because Respondents failed to include necessary documentation

including the ingredient lot numbers manufacturers name andor ingredient expiration dates

Respondents failed to include the generic active ingredients on many of the labels on the

compounded drugs

39 The inspectors noticed that Respondents had a number of containers labeled sample I cream on the premises Respondents said that occasionally when their customers had to wait

for approval from their insurance companies for payment for a compound drug Respondents

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staff members would ask the patients physicians for permission to provide sample creams

during the interim period

40 One of Respondents pharmacy technicians would speak with patients physicians

offices to ask for approval to give patients sample cream The technicians would write down

the order for the sample cream on the original prescription copy The sample creams contained

dangerous drugs The orders were not valid prescriptions because a pharmacist did not orally

receive them and a physician did not handwrite or transmit them The approved prescriptions

were incomplete because they did not include the name of the physicians offices staff member

who authorized the prescription the list of ingredients the quantity or length of time directions

or the initials of Respondents staff member who received the oral prescription

41 Many of the compound prescriptions were on pre-printed prescription forms provided

by Respondents to the patients physicians offices Respondents preprinted prescription forms

which included controlled substance prescriptions were multiple check-off prescription blank

forms Three ofthe prescription formulas on the preprinted prescription forms contained

ketamine a controlled substance Prescriptions for controlled substance are required to be

written on a secure blank prescription form faxed with a physicians signature and date or orally

prescribed by the patients physician to the pharmacist Respondents controlled substance preshy

printed prescriptions were not on secure blank prescription forms or orally received by

Respondents pharmacists

42 On one of the physician-approved prescriptions for the Schedule lii controlled

substance ketamine the physician authorized 11 refills and did not record the date on which she

approved the prescription

43 Respondents failed to identify ketamine as a Schedule lii controlled substance in their

compounding software program Due to this oversight Respondents did not record prescriptions

using or incorporating ketamine as controlled substance prescriptions Respondents did not

ensure that prescriptions using or incorporating ketamine were written on secure blank

prescription forms or that oral prescriptions using or incorporating ketamine were only received

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by the pharmacist Respondents did not report prescriptions using or incorporating ketamine to

the Controlled Substance Utilization Review and Evaluation System (CURES)

44 On or about December 17 2013 Respondents dispensed a prescription for T3fT4

Mixture C 2080 mg capsules A qualitative analysis report taken on or about February 21 2014

revealed that the T4 (Levothyroxine Sodium) component of the compounded drug was sub-potent

because the T 4 was 735 of the expected potency

FIRST CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(l))

45 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in ink by

the prescribers (Health amp Saf Codesect 11164 subd (a)(1)) The circumstances are further

explained in paragraphs 30 to 32 above

SECOND CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

46 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action

because it filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Code sect 11167) Respondent San Dimas also failed to obtain the

original prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

THIRD CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Prof Codesect 4301 subd (f))

47 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging in unprofessional conduct because it committed acts involving fraud (Bus amp Prof

Codesect 4301 subd (f)) Respondent San Dimas left a balance of medications owing on 178 of

the prescriptions it sold The circumstances are further explained in paragraphs 34 to 35 above

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FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

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SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

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and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

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THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

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SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

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then dispensed by another pharmacist the dispensing pharmacist shall also initial the prescription

to identify him or herself All orally transmitted prescriptions shall be received and transcribed by

a pharmacist prior to compounding filling dispensing or furnishing Chart orders as defined in

section 4019 of the Business and Professions Code are not subject to the provisions of this

subsection

16 California Code of Regulations title 16 section 17352 states in pertinent part

(f) The pharmacist performing or supervising compounding is responsible for the integrity

potency quality and labeled strength of a compounded drug product until it is dispensed

(h) Every compounded drug product shall be given an expiration date representing the date

beyond which in the professional judgment of the pharmacist performing or supervising the

compounding it should not be used This beyond use date of the compounded drug product

shall not exceed 180 days from preparation or the shortest expiration date of any component in

the compounded drug product unless a longer date is supported by stability studies of finished

drugs or compounded drug products using the same components and packaging Shorter dating

than set forth in this subsection may be used if it is deemed appropriate in the professional

judgment of the responsible pharmacist

17 California Code of Regulations title 16 section 17353 states in pertinent part

(a) For each compounded drug product the pharmacy records shall include

(I) The master formula record

(2) The date the drug product was compounded

(3) The identity of the pharmacy personnel who compounded the drug product

(4) The identity of the pharmacist reviewing the final drug product

(5) The quantity of each component used in compounding the drug product

~(6) The manufacturer expiration date and lot number of each component lfthe

manufacturer name is demonstrably unavailable the name of the supplier may be substituted

Exempt from the requirements in this paragraph are sterile products compounded on a one-time

basis for administration within seventy-two (72) hours and stored in accordance with standards

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for Redispensed CSPS found in Chapter 797 of the United States Pharmacopeia- National

Formulary (USP-NF) (35th Revision Effective May I 2012) hereby incorporated by reference

to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code

(7) A pharmacy assigned reference or lot number for the compounded drug product

(8) The expiration date of the final compounded drug product

(9) The quantity or amount of drug product compounded

18 Code of Federal Regulations title 21 section 130404 states in pertinent part

(f) Each registered manufacturer distributor importer exporter narcotic treatment

program and compounder for narcotic treatment program shall maintain inventories and records

of controlled substances as follows

(2) Inventories and records of controlled substances listed in Schedules III IV and V shall

be maintained either separately from all other records of the registrant or in such form that the

information required is readily retrievable from the ordinary business records of the registrant

CONTROLLED SUBSTANCES

19 Section 4021 of the Code states

Controlled substance means any substance listed in Chapter 2 (commencing with Section

11 053) of Division 10 of the Health and Safety Code

20 Oxycodone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(M)

21 Morphine is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(L)

22 Vyvanase is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (d)2)

23 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)(14)

24 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)14)

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25 Ketamine is a Schedule III controlled substance as designated by Health and Safety

Code section II 056 subdivision (g)

COST RECOVERY

26 Code section 1253 states in part that the Board may request the administrative law

judge to direct a licentiate found to have committed a violation or violations of the licensing act

to pay a sum not to exceed the reasonable costs of the investigation and enforcement of the case

FACTUALSTATEMENT

27 From about January 1 2008 to the present Respondent San Dimas Pharmacy amp

Compounding Center (Respondent San Dimas) has been operating as a pharmacy in Bakersfield

California From about January 7 2008 to the present Kalpana Patel (Respondent Patel) has

been the pharmacist-in-charge (PIC) at Respondent San Dimas

2012 Complaint and Investigation

28 On or about May 9 2012 a private individual submitted an online complaint to the

Board alleging that Respondent San Dimas was committing various license violations including

filling faxed copies of prescriptions in non-emergency situations and failing to obtain the original

hard copies of the prescriptions until much later and sometimes submitting invoices to insurance

companies for larger quantities of medication than the pharmacy actually dispensed to the

insurance companies customers and never giving the customers their remaining balance of

medication

29 On or about August 292012 in response to the complaint a Board inspector

(inspector) conducted an inspection at Respondent San Dimas

30 While at the pharmacy the inspector found five prescriptions for Schedule II

controlled substances that the pharmacy had filled even though the prescriptions were not signed

and dated in ink by the original prescriber The specifics ofthe five prescriptions are as follows

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a A prescription dated August 24 2012 for oxycodone The prescription was a

photocopy of the original prescription The prescription was not signed and dated in ink by the

prescriber

b A prescription dated March 15 2012 for methadone The prescription was on a

faxed refill authorization request form The prescription was not signed and dated in ink by the

prescriber

c A prescription dated March 172012 for morphine The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

d A prescription dated April 6 2012 for oxycodone The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

e A prescription dated May 162012 for Vyvanse The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

31 Respondent Patel told the inspector that she filled these five prescriptions for

Schedule II controlled substances without the required signatures because there was a possibility

the patients would run out of their medications while their doctors offices were closed The

inspector informed Respondent Patel that she could not provide Schedule II controlled substances

without a properly signed prescription unless there was a true emergency situation meaning that

not providing the medication would result in harm to the patient The inspector did not believe

that the patients with the five prescriptions in question had been in true emergency situations

32 Respondents San Dimas and Patel did not obtain the original prescriptions signed

and dated in ink by the prescriber within seven days of filling the prescriptions The investigator

asked Respondents San Dimas and Patel to show her the original prescriptions but they could not

produce these documents

33 The inspector found a folder in the pharmacy containing many labels bearing the

words balance owed The inspector determined that these labels showed the quantity of

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medications still owed to patients on prescriptions that they had purchased from Respondent San

Dimas

34 Respondent Patel did not reverse the insurance claims she submitted for the

prescriptions where there was a balanced owed She also did not resubmit the claims for the

actual quantity of medication the pharmacy had provided to the patient Respondent Patel instead

waited for the patients who were owed additional medication to return to the pharmacy to request

the balance owed

35 From approximately September 24 2010 to August 152012 Respondents San

Dimas and Patel failed to completely fill 178 prescriptions and submit invoices to the insurance

companies for the amount of medication the pharmacy actually dispensed None of the patients

for these 178 prescriptions returned to the pharmacy and claimed their owed balances of

medication

2013 Investigation

36 On or about August 282013 Board inspectors (inspectors) conducted another

inspection at Respondent San Dimas

37 One of the inspectors found that Respondents had expired and non-expired bulk stock

medications intermixed on their active use medication shelving The inspector reviewed

Respondents completed compounding log sheets and found that several of the expired products

had been used to prepare compounded products with an assigned beyond use date greater than the

expiration date of at least one of the ingredients

38 The inspectors notiCed that a number of entries on Respondents compounding log

sheets were incomplete because Respondents failed to include necessary documentation

including the ingredient lot numbers manufacturers name andor ingredient expiration dates

Respondents failed to include the generic active ingredients on many of the labels on the

compounded drugs

39 The inspectors noticed that Respondents had a number of containers labeled sample I cream on the premises Respondents said that occasionally when their customers had to wait

for approval from their insurance companies for payment for a compound drug Respondents

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staff members would ask the patients physicians for permission to provide sample creams

during the interim period

40 One of Respondents pharmacy technicians would speak with patients physicians

offices to ask for approval to give patients sample cream The technicians would write down

the order for the sample cream on the original prescription copy The sample creams contained

dangerous drugs The orders were not valid prescriptions because a pharmacist did not orally

receive them and a physician did not handwrite or transmit them The approved prescriptions

were incomplete because they did not include the name of the physicians offices staff member

who authorized the prescription the list of ingredients the quantity or length of time directions

or the initials of Respondents staff member who received the oral prescription

41 Many of the compound prescriptions were on pre-printed prescription forms provided

by Respondents to the patients physicians offices Respondents preprinted prescription forms

which included controlled substance prescriptions were multiple check-off prescription blank

forms Three ofthe prescription formulas on the preprinted prescription forms contained

ketamine a controlled substance Prescriptions for controlled substance are required to be

written on a secure blank prescription form faxed with a physicians signature and date or orally

prescribed by the patients physician to the pharmacist Respondents controlled substance preshy

printed prescriptions were not on secure blank prescription forms or orally received by

Respondents pharmacists

42 On one of the physician-approved prescriptions for the Schedule lii controlled

substance ketamine the physician authorized 11 refills and did not record the date on which she

approved the prescription

43 Respondents failed to identify ketamine as a Schedule lii controlled substance in their

compounding software program Due to this oversight Respondents did not record prescriptions

using or incorporating ketamine as controlled substance prescriptions Respondents did not

ensure that prescriptions using or incorporating ketamine were written on secure blank

prescription forms or that oral prescriptions using or incorporating ketamine were only received

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by the pharmacist Respondents did not report prescriptions using or incorporating ketamine to

the Controlled Substance Utilization Review and Evaluation System (CURES)

44 On or about December 17 2013 Respondents dispensed a prescription for T3fT4

Mixture C 2080 mg capsules A qualitative analysis report taken on or about February 21 2014

revealed that the T4 (Levothyroxine Sodium) component of the compounded drug was sub-potent

because the T 4 was 735 of the expected potency

FIRST CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(l))

45 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in ink by

the prescribers (Health amp Saf Codesect 11164 subd (a)(1)) The circumstances are further

explained in paragraphs 30 to 32 above

SECOND CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

46 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action

because it filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Code sect 11167) Respondent San Dimas also failed to obtain the

original prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

THIRD CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Prof Codesect 4301 subd (f))

47 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging in unprofessional conduct because it committed acts involving fraud (Bus amp Prof

Codesect 4301 subd (f)) Respondent San Dimas left a balance of medications owing on 178 of

the prescriptions it sold The circumstances are further explained in paragraphs 34 to 35 above

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FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

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SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

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and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

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THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

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SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

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for Redispensed CSPS found in Chapter 797 of the United States Pharmacopeia- National

Formulary (USP-NF) (35th Revision Effective May I 2012) hereby incorporated by reference

to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code

(7) A pharmacy assigned reference or lot number for the compounded drug product

(8) The expiration date of the final compounded drug product

(9) The quantity or amount of drug product compounded

18 Code of Federal Regulations title 21 section 130404 states in pertinent part

(f) Each registered manufacturer distributor importer exporter narcotic treatment

program and compounder for narcotic treatment program shall maintain inventories and records

of controlled substances as follows

(2) Inventories and records of controlled substances listed in Schedules III IV and V shall

be maintained either separately from all other records of the registrant or in such form that the

information required is readily retrievable from the ordinary business records of the registrant

CONTROLLED SUBSTANCES

19 Section 4021 of the Code states

Controlled substance means any substance listed in Chapter 2 (commencing with Section

11 053) of Division 10 of the Health and Safety Code

20 Oxycodone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(M)

21 Morphine is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (b)1)(L)

22 Vyvanase is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (d)2)

23 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)(14)

24 Methadone is a Schedule II controlled substance as designated by Health and Safety

Code section 11055 subdivision (c)14)

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25 Ketamine is a Schedule III controlled substance as designated by Health and Safety

Code section II 056 subdivision (g)

COST RECOVERY

26 Code section 1253 states in part that the Board may request the administrative law

judge to direct a licentiate found to have committed a violation or violations of the licensing act

to pay a sum not to exceed the reasonable costs of the investigation and enforcement of the case

FACTUALSTATEMENT

27 From about January 1 2008 to the present Respondent San Dimas Pharmacy amp

Compounding Center (Respondent San Dimas) has been operating as a pharmacy in Bakersfield

California From about January 7 2008 to the present Kalpana Patel (Respondent Patel) has

been the pharmacist-in-charge (PIC) at Respondent San Dimas

2012 Complaint and Investigation

28 On or about May 9 2012 a private individual submitted an online complaint to the

Board alleging that Respondent San Dimas was committing various license violations including

filling faxed copies of prescriptions in non-emergency situations and failing to obtain the original

hard copies of the prescriptions until much later and sometimes submitting invoices to insurance

companies for larger quantities of medication than the pharmacy actually dispensed to the

insurance companies customers and never giving the customers their remaining balance of

medication

29 On or about August 292012 in response to the complaint a Board inspector

(inspector) conducted an inspection at Respondent San Dimas

30 While at the pharmacy the inspector found five prescriptions for Schedule II

controlled substances that the pharmacy had filled even though the prescriptions were not signed

and dated in ink by the original prescriber The specifics ofthe five prescriptions are as follows

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a A prescription dated August 24 2012 for oxycodone The prescription was a

photocopy of the original prescription The prescription was not signed and dated in ink by the

prescriber

b A prescription dated March 15 2012 for methadone The prescription was on a

faxed refill authorization request form The prescription was not signed and dated in ink by the

prescriber

c A prescription dated March 172012 for morphine The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

d A prescription dated April 6 2012 for oxycodone The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

e A prescription dated May 162012 for Vyvanse The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

31 Respondent Patel told the inspector that she filled these five prescriptions for

Schedule II controlled substances without the required signatures because there was a possibility

the patients would run out of their medications while their doctors offices were closed The

inspector informed Respondent Patel that she could not provide Schedule II controlled substances

without a properly signed prescription unless there was a true emergency situation meaning that

not providing the medication would result in harm to the patient The inspector did not believe

that the patients with the five prescriptions in question had been in true emergency situations

32 Respondents San Dimas and Patel did not obtain the original prescriptions signed

and dated in ink by the prescriber within seven days of filling the prescriptions The investigator

asked Respondents San Dimas and Patel to show her the original prescriptions but they could not

produce these documents

33 The inspector found a folder in the pharmacy containing many labels bearing the

words balance owed The inspector determined that these labels showed the quantity of

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medications still owed to patients on prescriptions that they had purchased from Respondent San

Dimas

34 Respondent Patel did not reverse the insurance claims she submitted for the

prescriptions where there was a balanced owed She also did not resubmit the claims for the

actual quantity of medication the pharmacy had provided to the patient Respondent Patel instead

waited for the patients who were owed additional medication to return to the pharmacy to request

the balance owed

35 From approximately September 24 2010 to August 152012 Respondents San

Dimas and Patel failed to completely fill 178 prescriptions and submit invoices to the insurance

companies for the amount of medication the pharmacy actually dispensed None of the patients

for these 178 prescriptions returned to the pharmacy and claimed their owed balances of

medication

2013 Investigation

36 On or about August 282013 Board inspectors (inspectors) conducted another

inspection at Respondent San Dimas

37 One of the inspectors found that Respondents had expired and non-expired bulk stock

medications intermixed on their active use medication shelving The inspector reviewed

Respondents completed compounding log sheets and found that several of the expired products

had been used to prepare compounded products with an assigned beyond use date greater than the

expiration date of at least one of the ingredients

38 The inspectors notiCed that a number of entries on Respondents compounding log

sheets were incomplete because Respondents failed to include necessary documentation

including the ingredient lot numbers manufacturers name andor ingredient expiration dates

Respondents failed to include the generic active ingredients on many of the labels on the

compounded drugs

39 The inspectors noticed that Respondents had a number of containers labeled sample I cream on the premises Respondents said that occasionally when their customers had to wait

for approval from their insurance companies for payment for a compound drug Respondents

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staff members would ask the patients physicians for permission to provide sample creams

during the interim period

40 One of Respondents pharmacy technicians would speak with patients physicians

offices to ask for approval to give patients sample cream The technicians would write down

the order for the sample cream on the original prescription copy The sample creams contained

dangerous drugs The orders were not valid prescriptions because a pharmacist did not orally

receive them and a physician did not handwrite or transmit them The approved prescriptions

were incomplete because they did not include the name of the physicians offices staff member

who authorized the prescription the list of ingredients the quantity or length of time directions

or the initials of Respondents staff member who received the oral prescription

41 Many of the compound prescriptions were on pre-printed prescription forms provided

by Respondents to the patients physicians offices Respondents preprinted prescription forms

which included controlled substance prescriptions were multiple check-off prescription blank

forms Three ofthe prescription formulas on the preprinted prescription forms contained

ketamine a controlled substance Prescriptions for controlled substance are required to be

written on a secure blank prescription form faxed with a physicians signature and date or orally

prescribed by the patients physician to the pharmacist Respondents controlled substance preshy

printed prescriptions were not on secure blank prescription forms or orally received by

Respondents pharmacists

42 On one of the physician-approved prescriptions for the Schedule lii controlled

substance ketamine the physician authorized 11 refills and did not record the date on which she

approved the prescription

43 Respondents failed to identify ketamine as a Schedule lii controlled substance in their

compounding software program Due to this oversight Respondents did not record prescriptions

using or incorporating ketamine as controlled substance prescriptions Respondents did not

ensure that prescriptions using or incorporating ketamine were written on secure blank

prescription forms or that oral prescriptions using or incorporating ketamine were only received

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by the pharmacist Respondents did not report prescriptions using or incorporating ketamine to

the Controlled Substance Utilization Review and Evaluation System (CURES)

44 On or about December 17 2013 Respondents dispensed a prescription for T3fT4

Mixture C 2080 mg capsules A qualitative analysis report taken on or about February 21 2014

revealed that the T4 (Levothyroxine Sodium) component of the compounded drug was sub-potent

because the T 4 was 735 of the expected potency

FIRST CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(l))

45 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in ink by

the prescribers (Health amp Saf Codesect 11164 subd (a)(1)) The circumstances are further

explained in paragraphs 30 to 32 above

SECOND CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

46 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action

because it filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Code sect 11167) Respondent San Dimas also failed to obtain the

original prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

THIRD CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Prof Codesect 4301 subd (f))

47 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging in unprofessional conduct because it committed acts involving fraud (Bus amp Prof

Codesect 4301 subd (f)) Respondent San Dimas left a balance of medications owing on 178 of

the prescriptions it sold The circumstances are further explained in paragraphs 34 to 35 above

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FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

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SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

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and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

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THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

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SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

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25 Ketamine is a Schedule III controlled substance as designated by Health and Safety

Code section II 056 subdivision (g)

COST RECOVERY

26 Code section 1253 states in part that the Board may request the administrative law

judge to direct a licentiate found to have committed a violation or violations of the licensing act

to pay a sum not to exceed the reasonable costs of the investigation and enforcement of the case

FACTUALSTATEMENT

27 From about January 1 2008 to the present Respondent San Dimas Pharmacy amp

Compounding Center (Respondent San Dimas) has been operating as a pharmacy in Bakersfield

California From about January 7 2008 to the present Kalpana Patel (Respondent Patel) has

been the pharmacist-in-charge (PIC) at Respondent San Dimas

2012 Complaint and Investigation

28 On or about May 9 2012 a private individual submitted an online complaint to the

Board alleging that Respondent San Dimas was committing various license violations including

filling faxed copies of prescriptions in non-emergency situations and failing to obtain the original

hard copies of the prescriptions until much later and sometimes submitting invoices to insurance

companies for larger quantities of medication than the pharmacy actually dispensed to the

insurance companies customers and never giving the customers their remaining balance of

medication

29 On or about August 292012 in response to the complaint a Board inspector

(inspector) conducted an inspection at Respondent San Dimas

30 While at the pharmacy the inspector found five prescriptions for Schedule II

controlled substances that the pharmacy had filled even though the prescriptions were not signed

and dated in ink by the original prescriber The specifics ofthe five prescriptions are as follows

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a A prescription dated August 24 2012 for oxycodone The prescription was a

photocopy of the original prescription The prescription was not signed and dated in ink by the

prescriber

b A prescription dated March 15 2012 for methadone The prescription was on a

faxed refill authorization request form The prescription was not signed and dated in ink by the

prescriber

c A prescription dated March 172012 for morphine The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

d A prescription dated April 6 2012 for oxycodone The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

e A prescription dated May 162012 for Vyvanse The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

31 Respondent Patel told the inspector that she filled these five prescriptions for

Schedule II controlled substances without the required signatures because there was a possibility

the patients would run out of their medications while their doctors offices were closed The

inspector informed Respondent Patel that she could not provide Schedule II controlled substances

without a properly signed prescription unless there was a true emergency situation meaning that

not providing the medication would result in harm to the patient The inspector did not believe

that the patients with the five prescriptions in question had been in true emergency situations

32 Respondents San Dimas and Patel did not obtain the original prescriptions signed

and dated in ink by the prescriber within seven days of filling the prescriptions The investigator

asked Respondents San Dimas and Patel to show her the original prescriptions but they could not

produce these documents

33 The inspector found a folder in the pharmacy containing many labels bearing the

words balance owed The inspector determined that these labels showed the quantity of

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medications still owed to patients on prescriptions that they had purchased from Respondent San

Dimas

34 Respondent Patel did not reverse the insurance claims she submitted for the

prescriptions where there was a balanced owed She also did not resubmit the claims for the

actual quantity of medication the pharmacy had provided to the patient Respondent Patel instead

waited for the patients who were owed additional medication to return to the pharmacy to request

the balance owed

35 From approximately September 24 2010 to August 152012 Respondents San

Dimas and Patel failed to completely fill 178 prescriptions and submit invoices to the insurance

companies for the amount of medication the pharmacy actually dispensed None of the patients

for these 178 prescriptions returned to the pharmacy and claimed their owed balances of

medication

2013 Investigation

36 On or about August 282013 Board inspectors (inspectors) conducted another

inspection at Respondent San Dimas

37 One of the inspectors found that Respondents had expired and non-expired bulk stock

medications intermixed on their active use medication shelving The inspector reviewed

Respondents completed compounding log sheets and found that several of the expired products

had been used to prepare compounded products with an assigned beyond use date greater than the

expiration date of at least one of the ingredients

38 The inspectors notiCed that a number of entries on Respondents compounding log

sheets were incomplete because Respondents failed to include necessary documentation

including the ingredient lot numbers manufacturers name andor ingredient expiration dates

Respondents failed to include the generic active ingredients on many of the labels on the

compounded drugs

39 The inspectors noticed that Respondents had a number of containers labeled sample I cream on the premises Respondents said that occasionally when their customers had to wait

for approval from their insurance companies for payment for a compound drug Respondents

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staff members would ask the patients physicians for permission to provide sample creams

during the interim period

40 One of Respondents pharmacy technicians would speak with patients physicians

offices to ask for approval to give patients sample cream The technicians would write down

the order for the sample cream on the original prescription copy The sample creams contained

dangerous drugs The orders were not valid prescriptions because a pharmacist did not orally

receive them and a physician did not handwrite or transmit them The approved prescriptions

were incomplete because they did not include the name of the physicians offices staff member

who authorized the prescription the list of ingredients the quantity or length of time directions

or the initials of Respondents staff member who received the oral prescription

41 Many of the compound prescriptions were on pre-printed prescription forms provided

by Respondents to the patients physicians offices Respondents preprinted prescription forms

which included controlled substance prescriptions were multiple check-off prescription blank

forms Three ofthe prescription formulas on the preprinted prescription forms contained

ketamine a controlled substance Prescriptions for controlled substance are required to be

written on a secure blank prescription form faxed with a physicians signature and date or orally

prescribed by the patients physician to the pharmacist Respondents controlled substance preshy

printed prescriptions were not on secure blank prescription forms or orally received by

Respondents pharmacists

42 On one of the physician-approved prescriptions for the Schedule lii controlled

substance ketamine the physician authorized 11 refills and did not record the date on which she

approved the prescription

43 Respondents failed to identify ketamine as a Schedule lii controlled substance in their

compounding software program Due to this oversight Respondents did not record prescriptions

using or incorporating ketamine as controlled substance prescriptions Respondents did not

ensure that prescriptions using or incorporating ketamine were written on secure blank

prescription forms or that oral prescriptions using or incorporating ketamine were only received

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by the pharmacist Respondents did not report prescriptions using or incorporating ketamine to

the Controlled Substance Utilization Review and Evaluation System (CURES)

44 On or about December 17 2013 Respondents dispensed a prescription for T3fT4

Mixture C 2080 mg capsules A qualitative analysis report taken on or about February 21 2014

revealed that the T4 (Levothyroxine Sodium) component of the compounded drug was sub-potent

because the T 4 was 735 of the expected potency

FIRST CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(l))

45 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in ink by

the prescribers (Health amp Saf Codesect 11164 subd (a)(1)) The circumstances are further

explained in paragraphs 30 to 32 above

SECOND CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

46 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action

because it filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Code sect 11167) Respondent San Dimas also failed to obtain the

original prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

THIRD CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Prof Codesect 4301 subd (f))

47 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging in unprofessional conduct because it committed acts involving fraud (Bus amp Prof

Codesect 4301 subd (f)) Respondent San Dimas left a balance of medications owing on 178 of

the prescriptions it sold The circumstances are further explained in paragraphs 34 to 35 above

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FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

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SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

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and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

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THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

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SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

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a A prescription dated August 24 2012 for oxycodone The prescription was a

photocopy of the original prescription The prescription was not signed and dated in ink by the

prescriber

b A prescription dated March 15 2012 for methadone The prescription was on a

faxed refill authorization request form The prescription was not signed and dated in ink by the

prescriber

c A prescription dated March 172012 for morphine The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

d A prescription dated April 6 2012 for oxycodone The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

e A prescription dated May 162012 for Vyvanse The prescription was on a faxed

refill authorization request form The prescription was not signed and dated in ink by the

prescriber

31 Respondent Patel told the inspector that she filled these five prescriptions for

Schedule II controlled substances without the required signatures because there was a possibility

the patients would run out of their medications while their doctors offices were closed The

inspector informed Respondent Patel that she could not provide Schedule II controlled substances

without a properly signed prescription unless there was a true emergency situation meaning that

not providing the medication would result in harm to the patient The inspector did not believe

that the patients with the five prescriptions in question had been in true emergency situations

32 Respondents San Dimas and Patel did not obtain the original prescriptions signed

and dated in ink by the prescriber within seven days of filling the prescriptions The investigator

asked Respondents San Dimas and Patel to show her the original prescriptions but they could not

produce these documents

33 The inspector found a folder in the pharmacy containing many labels bearing the

words balance owed The inspector determined that these labels showed the quantity of

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medications still owed to patients on prescriptions that they had purchased from Respondent San

Dimas

34 Respondent Patel did not reverse the insurance claims she submitted for the

prescriptions where there was a balanced owed She also did not resubmit the claims for the

actual quantity of medication the pharmacy had provided to the patient Respondent Patel instead

waited for the patients who were owed additional medication to return to the pharmacy to request

the balance owed

35 From approximately September 24 2010 to August 152012 Respondents San

Dimas and Patel failed to completely fill 178 prescriptions and submit invoices to the insurance

companies for the amount of medication the pharmacy actually dispensed None of the patients

for these 178 prescriptions returned to the pharmacy and claimed their owed balances of

medication

2013 Investigation

36 On or about August 282013 Board inspectors (inspectors) conducted another

inspection at Respondent San Dimas

37 One of the inspectors found that Respondents had expired and non-expired bulk stock

medications intermixed on their active use medication shelving The inspector reviewed

Respondents completed compounding log sheets and found that several of the expired products

had been used to prepare compounded products with an assigned beyond use date greater than the

expiration date of at least one of the ingredients

38 The inspectors notiCed that a number of entries on Respondents compounding log

sheets were incomplete because Respondents failed to include necessary documentation

including the ingredient lot numbers manufacturers name andor ingredient expiration dates

Respondents failed to include the generic active ingredients on many of the labels on the

compounded drugs

39 The inspectors noticed that Respondents had a number of containers labeled sample I cream on the premises Respondents said that occasionally when their customers had to wait

for approval from their insurance companies for payment for a compound drug Respondents

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staff members would ask the patients physicians for permission to provide sample creams

during the interim period

40 One of Respondents pharmacy technicians would speak with patients physicians

offices to ask for approval to give patients sample cream The technicians would write down

the order for the sample cream on the original prescription copy The sample creams contained

dangerous drugs The orders were not valid prescriptions because a pharmacist did not orally

receive them and a physician did not handwrite or transmit them The approved prescriptions

were incomplete because they did not include the name of the physicians offices staff member

who authorized the prescription the list of ingredients the quantity or length of time directions

or the initials of Respondents staff member who received the oral prescription

41 Many of the compound prescriptions were on pre-printed prescription forms provided

by Respondents to the patients physicians offices Respondents preprinted prescription forms

which included controlled substance prescriptions were multiple check-off prescription blank

forms Three ofthe prescription formulas on the preprinted prescription forms contained

ketamine a controlled substance Prescriptions for controlled substance are required to be

written on a secure blank prescription form faxed with a physicians signature and date or orally

prescribed by the patients physician to the pharmacist Respondents controlled substance preshy

printed prescriptions were not on secure blank prescription forms or orally received by

Respondents pharmacists

42 On one of the physician-approved prescriptions for the Schedule lii controlled

substance ketamine the physician authorized 11 refills and did not record the date on which she

approved the prescription

43 Respondents failed to identify ketamine as a Schedule lii controlled substance in their

compounding software program Due to this oversight Respondents did not record prescriptions

using or incorporating ketamine as controlled substance prescriptions Respondents did not

ensure that prescriptions using or incorporating ketamine were written on secure blank

prescription forms or that oral prescriptions using or incorporating ketamine were only received

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by the pharmacist Respondents did not report prescriptions using or incorporating ketamine to

the Controlled Substance Utilization Review and Evaluation System (CURES)

44 On or about December 17 2013 Respondents dispensed a prescription for T3fT4

Mixture C 2080 mg capsules A qualitative analysis report taken on or about February 21 2014

revealed that the T4 (Levothyroxine Sodium) component of the compounded drug was sub-potent

because the T 4 was 735 of the expected potency

FIRST CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(l))

45 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in ink by

the prescribers (Health amp Saf Codesect 11164 subd (a)(1)) The circumstances are further

explained in paragraphs 30 to 32 above

SECOND CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

46 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action

because it filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Code sect 11167) Respondent San Dimas also failed to obtain the

original prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

THIRD CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Prof Codesect 4301 subd (f))

47 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging in unprofessional conduct because it committed acts involving fraud (Bus amp Prof

Codesect 4301 subd (f)) Respondent San Dimas left a balance of medications owing on 178 of

the prescriptions it sold The circumstances are further explained in paragraphs 34 to 35 above

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FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

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SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

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and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

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THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

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SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

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medications still owed to patients on prescriptions that they had purchased from Respondent San

Dimas

34 Respondent Patel did not reverse the insurance claims she submitted for the

prescriptions where there was a balanced owed She also did not resubmit the claims for the

actual quantity of medication the pharmacy had provided to the patient Respondent Patel instead

waited for the patients who were owed additional medication to return to the pharmacy to request

the balance owed

35 From approximately September 24 2010 to August 152012 Respondents San

Dimas and Patel failed to completely fill 178 prescriptions and submit invoices to the insurance

companies for the amount of medication the pharmacy actually dispensed None of the patients

for these 178 prescriptions returned to the pharmacy and claimed their owed balances of

medication

2013 Investigation

36 On or about August 282013 Board inspectors (inspectors) conducted another

inspection at Respondent San Dimas

37 One of the inspectors found that Respondents had expired and non-expired bulk stock

medications intermixed on their active use medication shelving The inspector reviewed

Respondents completed compounding log sheets and found that several of the expired products

had been used to prepare compounded products with an assigned beyond use date greater than the

expiration date of at least one of the ingredients

38 The inspectors notiCed that a number of entries on Respondents compounding log

sheets were incomplete because Respondents failed to include necessary documentation

including the ingredient lot numbers manufacturers name andor ingredient expiration dates

Respondents failed to include the generic active ingredients on many of the labels on the

compounded drugs

39 The inspectors noticed that Respondents had a number of containers labeled sample I cream on the premises Respondents said that occasionally when their customers had to wait

for approval from their insurance companies for payment for a compound drug Respondents

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staff members would ask the patients physicians for permission to provide sample creams

during the interim period

40 One of Respondents pharmacy technicians would speak with patients physicians

offices to ask for approval to give patients sample cream The technicians would write down

the order for the sample cream on the original prescription copy The sample creams contained

dangerous drugs The orders were not valid prescriptions because a pharmacist did not orally

receive them and a physician did not handwrite or transmit them The approved prescriptions

were incomplete because they did not include the name of the physicians offices staff member

who authorized the prescription the list of ingredients the quantity or length of time directions

or the initials of Respondents staff member who received the oral prescription

41 Many of the compound prescriptions were on pre-printed prescription forms provided

by Respondents to the patients physicians offices Respondents preprinted prescription forms

which included controlled substance prescriptions were multiple check-off prescription blank

forms Three ofthe prescription formulas on the preprinted prescription forms contained

ketamine a controlled substance Prescriptions for controlled substance are required to be

written on a secure blank prescription form faxed with a physicians signature and date or orally

prescribed by the patients physician to the pharmacist Respondents controlled substance preshy

printed prescriptions were not on secure blank prescription forms or orally received by

Respondents pharmacists

42 On one of the physician-approved prescriptions for the Schedule lii controlled

substance ketamine the physician authorized 11 refills and did not record the date on which she

approved the prescription

43 Respondents failed to identify ketamine as a Schedule lii controlled substance in their

compounding software program Due to this oversight Respondents did not record prescriptions

using or incorporating ketamine as controlled substance prescriptions Respondents did not

ensure that prescriptions using or incorporating ketamine were written on secure blank

prescription forms or that oral prescriptions using or incorporating ketamine were only received

12

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by the pharmacist Respondents did not report prescriptions using or incorporating ketamine to

the Controlled Substance Utilization Review and Evaluation System (CURES)

44 On or about December 17 2013 Respondents dispensed a prescription for T3fT4

Mixture C 2080 mg capsules A qualitative analysis report taken on or about February 21 2014

revealed that the T4 (Levothyroxine Sodium) component of the compounded drug was sub-potent

because the T 4 was 735 of the expected potency

FIRST CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(l))

45 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in ink by

the prescribers (Health amp Saf Codesect 11164 subd (a)(1)) The circumstances are further

explained in paragraphs 30 to 32 above

SECOND CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

46 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action

because it filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Code sect 11167) Respondent San Dimas also failed to obtain the

original prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

THIRD CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Prof Codesect 4301 subd (f))

47 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging in unprofessional conduct because it committed acts involving fraud (Bus amp Prof

Codesect 4301 subd (f)) Respondent San Dimas left a balance of medications owing on 178 of

the prescriptions it sold The circumstances are further explained in paragraphs 34 to 35 above

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Ill

Ill

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FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

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3

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SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

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and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

16

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THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

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SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

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staff members would ask the patients physicians for permission to provide sample creams

during the interim period

40 One of Respondents pharmacy technicians would speak with patients physicians

offices to ask for approval to give patients sample cream The technicians would write down

the order for the sample cream on the original prescription copy The sample creams contained

dangerous drugs The orders were not valid prescriptions because a pharmacist did not orally

receive them and a physician did not handwrite or transmit them The approved prescriptions

were incomplete because they did not include the name of the physicians offices staff member

who authorized the prescription the list of ingredients the quantity or length of time directions

or the initials of Respondents staff member who received the oral prescription

41 Many of the compound prescriptions were on pre-printed prescription forms provided

by Respondents to the patients physicians offices Respondents preprinted prescription forms

which included controlled substance prescriptions were multiple check-off prescription blank

forms Three ofthe prescription formulas on the preprinted prescription forms contained

ketamine a controlled substance Prescriptions for controlled substance are required to be

written on a secure blank prescription form faxed with a physicians signature and date or orally

prescribed by the patients physician to the pharmacist Respondents controlled substance preshy

printed prescriptions were not on secure blank prescription forms or orally received by

Respondents pharmacists

42 On one of the physician-approved prescriptions for the Schedule lii controlled

substance ketamine the physician authorized 11 refills and did not record the date on which she

approved the prescription

43 Respondents failed to identify ketamine as a Schedule lii controlled substance in their

compounding software program Due to this oversight Respondents did not record prescriptions

using or incorporating ketamine as controlled substance prescriptions Respondents did not

ensure that prescriptions using or incorporating ketamine were written on secure blank

prescription forms or that oral prescriptions using or incorporating ketamine were only received

12

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by the pharmacist Respondents did not report prescriptions using or incorporating ketamine to

the Controlled Substance Utilization Review and Evaluation System (CURES)

44 On or about December 17 2013 Respondents dispensed a prescription for T3fT4

Mixture C 2080 mg capsules A qualitative analysis report taken on or about February 21 2014

revealed that the T4 (Levothyroxine Sodium) component of the compounded drug was sub-potent

because the T 4 was 735 of the expected potency

FIRST CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(l))

45 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in ink by

the prescribers (Health amp Saf Codesect 11164 subd (a)(1)) The circumstances are further

explained in paragraphs 30 to 32 above

SECOND CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

46 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action

because it filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Code sect 11167) Respondent San Dimas also failed to obtain the

original prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

THIRD CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Prof Codesect 4301 subd (f))

47 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging in unprofessional conduct because it committed acts involving fraud (Bus amp Prof

Codesect 4301 subd (f)) Respondent San Dimas left a balance of medications owing on 178 of

the prescriptions it sold The circumstances are further explained in paragraphs 34 to 35 above

13

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FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

14

Accusation

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25

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I I

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21

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- - - - - -- - -- - ---2

3

4

SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

15

Accusation

5

10

15

20

25

6

7

8

9

II

12

13

14

16

17

18

19

21

22

23

24

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28

Ill

Ill

Ill

Ill

2

3

4

and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

16

Accusation

5

10

15

20

25

3

4

6

7

8

9

11

12

13

14

16

17

18

19

21

22

23

24

26

27

28

Ill

Ill

Ill

2

THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

17

Accusation

5

10

15

20

25

3

4

6

7

8

9

11

12

13

14

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28

2

SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

18

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

11

12

13

14

16

17

18

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

19

Accusation

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10

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20

25

2

3

4

6

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9

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12

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---1I

subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

20

Accusation

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10

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by the pharmacist Respondents did not report prescriptions using or incorporating ketamine to

the Controlled Substance Utilization Review and Evaluation System (CURES)

44 On or about December 17 2013 Respondents dispensed a prescription for T3fT4

Mixture C 2080 mg capsules A qualitative analysis report taken on or about February 21 2014

revealed that the T4 (Levothyroxine Sodium) component of the compounded drug was sub-potent

because the T 4 was 735 of the expected potency

FIRST CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(l))

45 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in ink by

the prescribers (Health amp Saf Codesect 11164 subd (a)(1)) The circumstances are further

explained in paragraphs 30 to 32 above

SECOND CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

46 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action

because it filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Code sect 11167) Respondent San Dimas also failed to obtain the

original prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

THIRD CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Prof Codesect 4301 subd (f))

47 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging in unprofessional conduct because it committed acts involving fraud (Bus amp Prof

Codesect 4301 subd (f)) Respondent San Dimas left a balance of medications owing on 178 of

the prescriptions it sold The circumstances are further explained in paragraphs 34 to 35 above

13

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

I I

12

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17

18

19

21

22

23

24

26

27

28

Ill

Ill

Ill

- - - -- -- - -- -- ----

FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

14

Accusation

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10

15

20

25

6

7

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9

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3

4

SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

15

Accusation

5

10

15

20

25

6

7

8

9

II

12

13

14

16

17

18

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21

22

23

24

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28

Ill

Ill

Ill

Ill

2

3

4

and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

16

Accusation

5

10

15

20

25

3

4

6

7

8

9

11

12

13

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17

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21

22

23

24

26

27

28

Ill

Ill

Ill

2

THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

17

Accusation

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10

15

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25

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2

SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

18

Accusation

5

10

15

20

25

2

3

4

6

7

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

19

Accusation

5

10

15

20

25

2

3

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

20

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

I I

12

13

14

16

17

18

19

21

22

23

24

26

27

28

Ill

Ill

Ill

- - - -- -- - -- -- ----

FOURTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

48 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

engaging ln unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (g)) Respondent San Dimas left a balance of medications owing on 178 of the

prescriptions it sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and the pharmacy failed to reverse these claims to the patients

insurance companies to reflect the actual quantity dispensed to the patients The circumstances

are further explained in paragraphs 34 to 35 above

FIFTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

49 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect 17353

subd (a)) A number of records were missing required information including the identity of the

manufacturer the lot number for each ingredient used in the compound and the expiration date

for each ingredient used in the compound The circumstances are further explained in paragraph

38 above

SIXTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17352 subd (h))

50 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient ofthe compounded drug (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraphs 37 above

14

Accusation

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3

4

SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

15

Accusation

5

10

15

20

25

6

7

8

9

II

12

13

14

16

17

18

19

21

22

23

24

26

27

28

Ill

Ill

Ill

Ill

2

3

4

and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

16

Accusation

5

10

15

20

25

3

4

6

7

8

9

11

12

13

14

16

17

18

19

21

22

23

24

26

27

28

Ill

Ill

Ill

2

THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

17

Accusation

5

10

15

20

25

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4

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7

8

9

11

12

13

14

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22

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27

28

2

SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

18

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

11

12

13

14

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17

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

19

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

II

12

13

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21

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---1I

subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

20

Accusation

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10

15

20

25

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7

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3

4

SEVENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)())

51 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)( I)) Respondent San Dimas filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraphs 39 to 40 above

EIGHTH CAUSE OF ACTION (Prescriptions Ftrnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

52 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not requiring the pharmacist to

receive transcribe and complete the prescription (Bus amp Prof Codesectsect 40404051 subd (a)

Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further explained in

paragraphs 39 to 41 above

NINTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2))

53 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule III controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CFR sect 130404 subd (f)(2)) Respndent

San Dimas did not identify ketamine powder as a Schedule III controlled substance separate

invoices involving ketamine powder from invoices not involving controlled substances and

identify prescriptions for medications containing ketamine as controlled substance prescriptions

In addition Respondent San Dimas did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by Respondent San Dimass

pharmacist Respondent San Dimas did not report prescriptions involving ketamine to CURES

15

Accusation

5

10

15

20

25

6

7

8

9

II

12

13

14

16

17

18

19

21

22

23

24

26

27

28

Ill

Ill

Ill

Ill

2

3

4

and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

16

Accusation

5

10

15

20

25

3

4

6

7

8

9

11

12

13

14

16

17

18

19

21

22

23

24

26

27

28

Ill

Ill

Ill

2

THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

17

Accusation

5

10

15

20

25

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4

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7

8

9

11

12

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2

SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

18

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

11

12

13

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17

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Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

19

Accusation

5

10

15

20

25

2

3

4

6

7

8

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

20

Accusation

5

10

15

20

25

6

7

8

9

II

12

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Ill

Ill

Ill

2

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and filled one that was authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TENTH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

54 Respondent San Dimas has subjected its Pharmacy Permit to disciplinary action by

failing to meet compounding requirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent San

Dimas and dispensed to a pateint was sub-potent The circumstances are further explained in

paragraph 44 above

ELEVENTII CAUSE OF ACTION (Failure to Follow Filling Requirements for Prescriptions for Controlled Substances)

(Health amp Saf Codesect 11164 subd (a)(1))

55 Respondent Patel has subjected her Pharmacist License to disciplinary action for

filling prescriptions for Schedule II controlled substances that were not signed and dated in by the

prescribers (Health amp Saf Codesect 11164 subd (a)( I)) The circumstances are further

explained in paragraphs 30 to 32 above

TWELFTH CAUSE OF ACTION (Failure to Follow Requirements for Dispensing Controlled Substances in Emergency Situations)

(Health amp Saf Code sect 11167)

56 Respondent Patel has subjected her Pharmacy Permit to disciplinary action because

she filled prescriptions not signed and dated in ink by the prescribers in non-emergency

situations (Health amp Saf Codesect 11167) Respondent Patel also failed to obtain the original

prescriptions signed and dated in ink by the prescribers within seven days of filling the

improperly formatted prescriptions The circumstances are further explained in paragraphs 30 to

33 above

16

Accusation

5

10

15

20

25

3

4

6

7

8

9

11

12

13

14

16

17

18

19

21

22

23

24

26

27

28

Ill

Ill

Ill

2

THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

17

Accusation

5

10

15

20

25

3

4

6

7

8

9

11

12

13

14

16

17

18

19

21

22

23

24

26

27

28

2

SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

18

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

11

12

13

14

16

17

18

19

21

22

23

24

26

27

28

Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

19

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

II

12

13

14

16

17

18

19

21

22

23

24

26

27

28

---1I

subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

20

Accusation

5

10

15

20

25

3

4

6

7

8

9

11

12

13

14

16

17

18

19

21

22

23

24

26

27

28

Ill

Ill

Ill

2

THIRTEENTH CAUSE OF ACTION (Unprofessional Conduct Fraud)

(Bus amp Pro[ Code sect 4301 subd (f))

57 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct because she committed acts involving fraud (Bus amp Prof

Code sect 4301 subd (g)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The circumstances are further explained in paragraphs 34 to 35 above

FOURTEENTH CAUSE OF ACTION (Unprofessional Conduct False Representation)

(Bus amp Prof Codesect 4301 subd (g))

58 Respondent Patel has subjected her Pharmacist License to disciplinary action by

engaging in unprofessional conduct by knowingly making or signing certificates or documents

that falsely represented the existence or nonexistence of a state of facts (Bus amp Prof Code sect

4301 subd (h)) Respondent Patel left a balance of medications owing on 178 of the

prescriptions she sold The patients for these 178 prescriptions did not receive their owed

quantities of medications and she failed to reverse these claims to the patients insurance

companies to reflect the aqtual quantity dispensed to the patients The circumstances are further

explained in paragraphs 34 to 35 above

FIFTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(Cal Code Regs tit 16 sect 17353 subd (a))

59 Respondent Patel has subjected her Pharmacist License to disciplinary action by

maintaining incomplete pharmacy compounding records (Cal Code Regs tit 16 sect I 735 3

subd (a)) A number of records at the pharmacy were missing required information including

the identity of the manufacturer the lot number for each ingredient used in the compound and the

expiration date for each ingredient used in the compound The circumstances are further

explained in paragraph 3 8 above

17

Accusation

5

10

15

20

25

3

4

6

7

8

9

11

12

13

14

16

17

18

19

21

22

23

24

26

27

28

2

SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

18

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

11

12

13

14

16

17

18

19

21

22

23

24

26

27

28

Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

19

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

II

12

13

14

16

17

18

19

21

22

23

24

26

27

28

---1I

subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

20

Accusation

5

10

15

20

25

3

4

6

7

8

9

11

12

13

14

16

17

18

19

21

22

23

24

26

27

28

2

SIXTEENTH CAUSE OF ACTION (Failure to Follow Compounding Limitations and Requirements)

(GaiCodeRegstitl6sect173S2subd(h))- middot -- shy

60 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing pharmacy staff to assign beyond use dates to compounded products which exceeded the

expiration date of at least one ingredient of the compounded product (Cal Code Regs tit 16 sect

17352 subd (h)) The circumstances are further explained in paragraph 37 above

SEVENTEENTH CAUSE OF ACTION (Failure to Follow Content Requirements for Prescriptions)

(Bus amp Prof Codesect 4040 subd (a)(l))

61 Respondent Patel has subjected her Pharmacist License to disciplinary action by

accepting prescriptions for compounded medications that did not contain all of the statutorily

required information (Bus amp Prof Codesect 4040 subd (a)(l)) Respondent Patel filled

prescriptions that did not contain the following required elements the name strength and

quantity of the drug prescribed and directions on how to use the medication The circumstances

are further explained in paragraph 39 to 40 above

EIGHTEENTH CAUSE OF ACTION (Prescriptions Furnished or Dispensed by Non-Pharmacist)

(Bus amp Prof Codesectsect 40404051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c))

62 Respondent Patel has subjected her Pharmacist License to disciplinary action by

allowing non-pharmacists to orally receive prescriptions and not receiving transcribing and

completing the prescription herself as the pharmacist-in-charge (Bus amp Prof Code sectsect 4040

4051 subd (a) Cal Code Regs tit 16 sect 1717 subd (c)) The circumstances are further

explained in paragraphs 39 to 41 above

NINETEENTH CAUSE OF ACTION (Failure to Properly Maintain Records)

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2))

63 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to properly maintain records for ketamine powder a Schedule JII controlled substance

(Health amp Saf Codesectsect 11200 subd (b) 11164 21 CPRsect 130404 subd (1)(2)) Respondent

18

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

11

12

13

14

16

17

18

19

21

22

23

24

26

27

28

Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

19

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

II

12

13

14

16

17

18

19

21

22

23

24

26

27

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---1I

subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

20

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

11

12

13

14

16

17

18

19

21

22

23

24

26

27

28

Patel did not identify ketamine powder as a Schedule lii controlled substance separate invoices

involving ketamine powder from invoices not involving controlled substances and identify

prescriptions for medications containing ketamine as controlled substance prescriptions In

addition Respondent Patel as did not require prescriptions involving ketamine powder to be

written on secure blank prescription forms or orally received by herself as Respondent San

Dimass sole pharmacist Respondent San Patel did not report prescriptions involving ketamine

to CURES and filled one that authorized for more than five refills The circumstances are further

explained in paragraphs 41 to 43 above

TWENTIETH CAUSE OF ACTION (Failure to Follow Compounding Requirements for Potency)

(Cal Code Regs tit 16 sect 17352 subd (f))

64 Respondent Patel has subjected her Pharmacist License to disciplinary action by

failing to meet compounding (equirements for potency (Cal Code Regs tit 16 sect 17352 subd

(f)) A qualitative analysis report revealed that a prescription compounded by Respondent Patel

had a component that was sub-potent The circumstances are further explained in paragraph 44

above

DISCIPLINARY CONSIDERATIONS

65 On or about May 232014 in the matter entitled People v KalpanaKalpeshkumar Patel

in Sacramento County Court Case No 14F03262 the Department ofJustice on behalfofthe People

ofthe State ofCalifornia charged Respondent Patel with submitting a false and fraudulent Medi-Cal

claim (Welfare amp Institutions Codesect 14107 subd (b)(l)) grand theft of personal property (Pen

Code sect 487 subd (a)) presentation of a fraudulent claim (Pen Code sect 72) and insurance fraud

(Pen Code sect550 subd (a)(6)) This matter is still pending

66 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about July 3 2013 in a prior action the Board of

Pharmacy issued Citation Number CI-2011-52726 and ordered Respondent San Dimas to pay a

$25000 fine for deviating from prescriptions (Cal Code Regs tit 16 sect 1716) a $25000 fine for

not following proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707

19

Accusation

5

10

15

20

25

2

3

4

6

7

8

9

II

12

13

14

16

17

18

19

21

22

23

24

26

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28

---1I

subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

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subds (e) (f)) a $50000 fine for engaging in compounding and failing to maintain proper

written documentation of its personnel having the necessary skills and training to maintain an

evaluation process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

prevent the sale of preparations or drugs that lacked quality or strength (Bus amp Prof Code sect

4342) a $100000 fine for failing to follow the requirement that a pharmacy with only one

pharmacist should have no more than one pharmacy technician performing tasks (Bus amp Prof

Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus amp Prof

Codesect 4301 subd U) 21 USC sectsect 802 822 21 CFR sect 130721 (2013)) and a $50000 fine

for failing to maintaining proper records for compounded drug products (Cal Code Regs tit 16

sect 17353 subd (a))

67 To determine the degree of discipline if any to be imposed on Respondent San

Dimas Complainant alleges that on or about December 15 20 I 0 in a prior action the Board of

Pharmacy issued Citation Number CI-2009-44507 and ordered Respondent San Dimas to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

68 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about July 3 2013 in a prior action the Board of Pharmacy

issued Citation Number Cl-2012-57375 and ordered Respondent Patel to pay a $50000 fine for

deviating from prescriptions (Cal Code Reg tit 16 sect 1716) a $25000 fine for not following

proper requirements for off-site storage of records (Cal Code Reg tit 16 sect 1707 subds (e)

(f)) a $50000 fine for engaging in compounding and failing to maintain proper written

documentation of its personnel having the necessary skills and training to maintain an evaluation

process for personnel involved in compounding to ensure that personnel involved in

compounding could demonstrate knowledge about processes and procedures used in

compounding (Cal Code Regs tit 16 sect 17357 subds (a) (b) (c)) a $25000 fine for failing to

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prevent the sale of pharmaceutical preparations or drugs that lacked quality or strength (Bus amp

Prof Code sect 4342) a $100000 fine for failing to follow the requirement that a pharmacy with

only one pharmacist should have no more than one pharmacy technician performing tasks (Bus

amp Prof Codesect 4115 subd (f)( I)) a $50000 fine for engaging in unprofessional conduct (Bus

amp Prof Codesect 4301 subd U) 21 USC sectsect 802 822 21 CPRsect 130721 (2013)) and a

$50000 fine for failing to maintaining proper records for compounded drug products (Cal Code

Reg tit 16 sect 17353 subd (a))

69 To determine the degree of discipline if any to be imposed on Respondent Patel

Complainant alleges that on or about December 15 2010 in a prior action the Board of

Pharmacy issued Citation Number CI-2010-46672 and ordered Respondent Patel to pay a

$50000 fine for failing to ensure that there was proper pharmacy security (Cal Code Regs tit

16 sect 1714 subd (b)) and a $50000 fine for allowing an unlicensed individual to act as a

pharmacy technician (Bus amp Prof Code sect 4115 subd (e))

PRAYER

WHEREFORE Complainant requests that a hearing be held on the matters alleged in this

Accusation and that following the hearing the Board of Pharmacy issue a decision

11 Revoking or suspending Pharmacy Permit Number PHY 48922 issued to San Dimas

Pharmacy amp Compounding Center

12 Revoking or suspending Pharmacist License Number RPH 49676 issued to Kalpana

Patel also known as Kalpana Kalpeshkumar Patel

13 Ordering San Dimas Pharmacy amp Compounding Center and Kalpana Patel also

known as Kalpana Kalpeshkumar Patel to pay the Board of Pharmacy the reasonable costs of the

investigation and enforcement of this case pursuant to Business and Professions Code section

1253

14 Pursuant to Business and Professions Code section 4307 if discipline is imposed on

Pharmacy Permit Number PHY 48922 issued to San Dimas Pharmacy amp Compounding Center

and Kalpana Patel also known as Kalpana Kalpeshkumar Patel (Patel) while acting as the

manager administrator owner member officer director associate or partner of San Dimas

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Pharmacy amp Compounding Center had knowledge of or knowingly participated in any conduct

for which Pharmacy Permit Number PHY 48922 issued to San Dimas Pharmacy amp

Compounding Center was revoked suspended or placed on probation Patel shall be prohibited

from serving as a manager administrator owner member officer director associate or partner

of a licensee for five years if Pharmacy Permit Number PHY 48922 issued to San Dimas

Pharmacy amp Compounding Center is placed on probation or until PHY 48922 issued to San

Dimas Pharmacy amp Compounding Center is reinstated if it is revoked and

15 Taking such other and further action as deemed necessary and proper

Exec i fficer Board of Pharmacy Department of Consumer Affairs State of California Complainant

SF20 14902425 90440380doc

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Accusation